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Farag A, Hendawy H, Emam MH, Hasegawa M, Mandour AS, Tanaka R. Stem Cell Therapies in Canine Cardiology: Comparative Efficacy, Emerging Trends, and Clinical Integration. Biomolecules 2025; 15:371. [PMID: 40149907 PMCID: PMC11940628 DOI: 10.3390/biom15030371] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/30/2025] [Revised: 02/26/2025] [Accepted: 02/27/2025] [Indexed: 03/29/2025] Open
Abstract
Cardiovascular diseases are a leading cause of morbidity and mortality in dogs, with limited options available for reversing myocardial damage. Stem cell therapies have shown significant potential for cardiac repair, owing to their immunomodulatory, antifibrotic, and regenerative properties. This review evaluates the therapeutic applications of mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue, and Wharton's jelly with a focus on their role in canine cardiology and their immunoregulatory properties. Preclinical studies have highlighted their efficacy in enhancing cardiac function, reducing fibrosis, and promoting angiogenesis. Various delivery methods, including intracoronary and intramyocardial injections, are assessed for their safety and efficacy. Challenges such as low cell retention, differentiation efficiency, and variability in therapeutic responses are also discussed. Emerging strategies, including genetic modifications and combination therapies, aim to enhance the efficacy of MSCs. Additionally, advances in delivery systems and regulatory frameworks are reviewed to support clinical translation. This comprehensive evaluation underscores the potential of stem cell therapies to revolutionize canine cardiovascular disease management while identifying critical areas for future research and clinical integration.
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Affiliation(s)
- Ahmed Farag
- Faculty of Agriculture, Veterinary Teaching Hospital, Tokyo University of Agriculture and Technology, Tokyo 183-8509, Japan
- Department of Surgery, Anesthesiology, and Radiology, Faculty of Veterinary Medicine, Zagazig University, Zagazig 44519, Egypt
| | - Hanan Hendawy
- Department of Veterinary Surgery, Faculty of Veterinary Medicine, Suez Canal University, Ismailia 41522, Egypt
| | - Mahmoud H. Emam
- Animal Medicine Department, Faculty of Veterinary Medicine, Zagazig University, Zagazig 44519, Egypt
| | - Mizuki Hasegawa
- Faculty of Agriculture, Veterinary Teaching Hospital, Tokyo University of Agriculture and Technology, Tokyo 183-8509, Japan
| | - Ahmed S. Mandour
- Department of Animal Medicine (Internal Medicine), Faculty of Veterinary Medicine, Suez Canal University, Ismailia 41522, Egypt
| | - Ryou Tanaka
- Faculty of Agriculture, Veterinary Teaching Hospital, Tokyo University of Agriculture and Technology, Tokyo 183-8509, Japan
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Gilat R, Muth SA, Hurley ET, Yazdi AA, Franzia CH, Rodeo SA, Shapiro SA, Frank RM, Cole BJ. Experts Achieve Consensus on a Majority of Statements Regarding Ethics, Transparency, Regulation, and Best Practices for the Use of Orthobiologics. Arthroscopy 2025:S0749-8063(25)00085-4. [PMID: 39938667 DOI: 10.1016/j.arthro.2025.01.062] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/30/2024] [Revised: 01/15/2025] [Accepted: 01/27/2025] [Indexed: 02/14/2025]
Abstract
PURPOSE To establish consensus statements via a modified Delphi process about ethics, transparency, regulation, and best practices for the use of orthobiologics in clinical practice for musculoskeletal pathology. METHODS A consensus process on the regulation of orthobiologics at the provider level was conducted using a modified Delphi technique. Twenty orthopaedic surgeons, sports medicine physicians, or basic scientists participated. Each participant was a Biologic Association member organization representative and asked to participate because of their active interest in the field of orthobiologics. Levels of consensus were delineated according to the number of votes for each statement: no consensus, <80%; consensus, 80% to 89%; strong consensus, 90% to 99%; unanimous, 100%. RESULTS The 26 consensus statements on orthobiologics resulted in 14 achieving unanimous consensus, 8 achieving strong consensus, 3 achieving consensus, and 1 did not achieve consensus. Overall, 85% of the statements reached either a unanimous or strong consensus. Of the statements regarding communication and transparency, 9 reached unanimous consensus, including information to convey and helpful tools to describe current orthobiologics, persistent misinformation, use of the word "stem cells," "off-label" use, and problems with the present regulatory environment. Five statements discussing the regulation of novel orthobiologics achieved unanimous consensus. These statements highlighted research regulation, safety, and suggested improvements to regulatory issues. The statement that did not achieve any consensus was on the regulatory processes that should be in place by an institution providing novel orthobiologic treatments. No statement reached a unanimous agreement on cost or ethical considerations. CONCLUSIONS This study successfully identified key consensus statements emphasizing the importance of ethics, transparency, and regulation in the use of orthobiologics, with 85% of statements reaching unanimous or strong consensus. These findings underscore the need for standardized communication, improved regulatory frameworks, and enhanced safety measures while highlighting persistent challenges in addressing cost and ethical considerations. LEVEL OF EVIDENCE Level V, expert opinion.
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Affiliation(s)
- Ron Gilat
- Midwest Orthopaedics at Rush University Medical Center, Chicago, Illinois, U.S.A.; Faculty of Medical and Health Sciences, Tel Aviv University, Israel
| | - Sarah A Muth
- Midwest Orthopaedics at Rush University Medical Center, Chicago, Illinois, U.S.A
| | - Eoghan T Hurley
- Department of Orthopaedic Surgery, Duke University, Durham, North Carolina, U.S.A
| | - Allen A Yazdi
- Midwest Orthopaedics at Rush University Medical Center, Chicago, Illinois, U.S.A
| | - Chloe H Franzia
- Midwest Orthopaedics at Rush University Medical Center, Chicago, Illinois, U.S.A
| | - Scott A Rodeo
- Department of Orthopaedic Surgery, Hospital for Special Surgery, Sports Medicine Institute, New York, New York, U.S.A
| | - Shane A Shapiro
- Mayo Clinic College of Medicine and Science, Mayo Clinic Department of Orthopedic Surgery, Jacksonville, Florida, U.S.A
| | - Rachel M Frank
- Department of Orthopaedic Surgery, University of Colorado School of Medicine, Denver, Colorado, U.S.A
| | - Brian J Cole
- Midwest Orthopaedics at Rush University Medical Center, Chicago, Illinois, U.S.A..
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Rees L, Friis T, Woodward-Kron R, Munsie M. What is known about healthcare professional-patient communication when discussing stem cell therapies? A scoping review. PATIENT EDUCATION AND COUNSELING 2025; 130:108430. [PMID: 39265452 DOI: 10.1016/j.pec.2024.108430] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/17/2024] [Revised: 08/12/2024] [Accepted: 09/05/2024] [Indexed: 09/14/2024]
Abstract
OBJECTIVES When therapeutic options are limited, patients may invest hope in therapies proposed by healthcare professional, or those they find online. This review aims to explore how healthcare professional-patient communication is realised when discussing stem cell therapies. METHOD Four electronic databases were systematically searched for relevant studies. Twenty-six studies met the inclusion criteria. Descriptive analyses and a thematic analysis guided by a functions of medical communication framework were performed on extracted data. RESULTS Most included studies addressed communication in contexts of conventional stem cell therapies, such as bone marrow transplants for blood cancers. Few studies investigated communication in contexts of experimental stem cell therapies yet to receive regulatory approval. Two themes were identified as informational and relational aspects of communication, and a third theme being a mismatch in orientations. CONCLUSIONS Communication between healthcare professionals and patients about stem cell therapies is practised using a combination of communication approaches that do not always align with patients' needs, hopes or expectations. PRACTICE IMPLICATIONS The context of healthcare settings and health conditions are important when communicating about stem cell therapies. Acknowledging healthcare professionals' environmental and personal determinants can inform strategies to navigate complex discussions about stem cell therapies with patients.
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Affiliation(s)
- Leanne Rees
- Murdoch Children's Research Institute, Melbourne, Australia; Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Australia.
| | - Tine Friis
- Medical Museion, University of Copenhagen, Copenhagen, Denmark.
| | - Robyn Woodward-Kron
- Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Australia.
| | - Megan Munsie
- Murdoch Children's Research Institute, Melbourne, Australia; Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Australia.
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Kalavar M, Lovett EA, Nicholas MP, Ross-Hirsch A, Nirwan RS, Sridhar J, Patel S, Flynn HW, Albini TA, Kuriyan AE. Update on "Cell Therapy" Clinics Offering Treatments of Ocular Conditions Using Direct-To-Consumer Marketing Websites in the U.S. Am J Ophthalmol 2024; 267:135-141. [PMID: 38880376 DOI: 10.1016/j.ajo.2024.06.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/18/2024] [Revised: 06/07/2024] [Accepted: 06/07/2024] [Indexed: 06/18/2024]
Abstract
PURPOSE To assess the scope of U.S.-based companies advertising and administering non-Federal Drug Administration (FDA) approved cell-based therapy (herein called NFACT) for ocular conditions based on information from companies' public websites after the FDA's legal actions against specific NFACT clinics in 2018 and 2019. Current findings are compared to previously published data from 2017. DESIGN Trend study looking at U.S.-based companies that use direct-to-consumer marketing and have websites advertising therapy for ocular conditions. METHODS A systematic and extensive keyword-based Internet search was utilized to identify, document, and analyze U.S. business websites offering NFACT for ocular conditions as of August 2022. Main outcomes measured include, clinic locations, marketed ocular conditions, types of NFACT offered, source of stem cells used, routes of administration, and treatment costs. RESULTS From the prior analysis in 2017 to the 2019 analysis, there was a decrease in the number of NFACT clinics from 76 to 62 and companies from 40 to 39. Given the concerning persistence of NFACTs in August 2019 an additional analysis was performed in 2022 which showed a drastic decrease in NFACT clinics from 62 in 2019 to 18 in 2023 and from 39 companies to 13 in 2023. In both 2019 and 2022, the most commonly referenced ocular condition was age-related macular degeneration (2019-72%, 2022-92%). The state with the most clinics was in Texas (2019-12; 2022-5). Autologous adipose-derived stem cells were the most common cell type used in both analyses. CONCLUSIONS In 2019 U.S.-based direct-to-consumer companies marketing NFACT persisted despite (1) a lack of high-quality clinical evidence supporting the efficacy of these procedures, (2) the association of some of these treatments with severe vision loss, and (3) increasing FDA oversight and recent legal action. In 2022 the number of clinics and companies decreased, but their persistence is a reminder that continued concern is necessary and ophthalmic associations need to continue advocacy efforts to protect patients from these potentially predatory organizations.
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Affiliation(s)
- Meghana Kalavar
- Havener Eye Institute, Ohio State University Wexner Medical Center (M.K.), Columbus, Ohio, USA
| | - Eric A Lovett
- Jacobs School of Medicine and Biomedical Sciences, University at Buffalo (E.A.L.), Buffalo, New York, USA
| | - Matthew P Nicholas
- Eye Disease Consultants, LLC (M.P.N.), West Hartford, Connecticut, USA; Hartford Hospital (M.P.N.), Hartford, Connecticut, USA; Flaum Eye Institute, University of Rochester Medical Center (M.P.N., R.S.N.), Rochester, New York, USA
| | - Adam Ross-Hirsch
- Department of Ophthalmology, SUNY Upstate Medical University (A.R.H.), Syracuse, New York, USA
| | - Rajinder S Nirwan
- Flaum Eye Institute, University of Rochester Medical Center (M.P.N., R.S.N.), Rochester, New York, USA
| | - Jayanth Sridhar
- Olive View Medical Center, University of California Los Angeles (J.S.), Los Angeles, California, USA
| | - Shriji Patel
- Department of Ophthalmology, Vanderbilt University Medical Center (S.P.), Nashville, Tennessee, USA
| | - Harry W Flynn
- Department of Ophthalmology, Bascom Palmer Eye Institute, The University of Miami (H.W.F., T.A.A.), Miami, Florida, USA
| | - Thomas A Albini
- Department of Ophthalmology, Bascom Palmer Eye Institute, The University of Miami (H.W.F., T.A.A.), Miami, Florida, USA
| | - Ajay E Kuriyan
- Mid Atlantic Retina/Retina Service, Wills Eye Hospital, Sidney Kimmel Medical College at Thomas Jefferson University (A.E.K.), Philadelphia, Pennsylvania, USA.
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Ikonomou L, Munsie M, Power C, Sipp D, Turner L, Rasko JEJ. Effective regulatory responses to predatory stem cell markets in Australia and Canada. Cell Stem Cell 2024; 31:1393-1397. [PMID: 39366360 DOI: 10.1016/j.stem.2024.09.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2024] [Revised: 08/22/2024] [Accepted: 09/09/2024] [Indexed: 10/06/2024]
Abstract
The rapid proliferation of businesses engaged in direct-to-consumer advertising of unproven stem cell interventions has raised troubling questions about whether government bodies can regulate this health market effectively. Recent developments in Australia and Canada suggest that such fears are unfounded and that targeted regulatory action can have meaningful effects.
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Affiliation(s)
- Laertis Ikonomou
- Department of Oral Biology, University at Buffalo, The State University of New York, Buffalo, NY, USA; Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, University at Buffalo, The State University of New York, Buffalo, NY, USA; Cell, Gene and Tissue Engineering Center, University at Buffalo, The State University of New York, Buffalo, NY, USA
| | - Megan Munsie
- Stem Cell Medicine Theme, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Medicine, University of Melbourne, Melbourne, VIC, Australia
| | - Carl Power
- Gene and Stem Cell Therapy Program, Centenary Institute, University of Sydney, Sydney, NSW, Australia
| | - Douglas Sipp
- RIKEN Center for Biosystems Dynamics Research, 2-2-3 Minatojima-minamimachi, Chuo-ku, Kobe 650-0047, Japan
| | - Leigh Turner
- Department of Health, Society, and Behavior, School of Population & Public Health, University of California, Irvine, Irvine, CA, USA; Center for Health Ethics, School of Population & Public Health, University of California, Irvine, Irvine, CA, USA; Stem Cell Research Center, University of California, Irvine, Irvine, CA, USA
| | - John E J Rasko
- Gene and Stem Cell Therapy Program, Centenary Institute, University of Sydney, Sydney, NSW, Australia; University of Sydney, Central Clinical School, Faculty of Medicine and Health, Sydney, NSW, Australia; Department of Cell and Molecular Therapies, Royal Prince Alfred Hospital, Sydney, NSW, Australia.
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6
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Brinsfield TN, Pinson NR, Levine AD. The evolution and ongoing challenge of unproven cell-based interventions. Stem Cells Transl Med 2024; 13:851-858. [PMID: 39045646 PMCID: PMC11386208 DOI: 10.1093/stcltm/szae050] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2023] [Accepted: 06/23/2024] [Indexed: 07/25/2024] Open
Abstract
Unproven cell-based interventions (CBIs) emerged early in the 2000s as a particularly problematic form of unproven therapy and remain a vexing policy problem to this day. These unproven interventions can harm patients both physically and financially and can complicate the process of developing a rigorous evidence base to support the translation of novel stem cell or other cell therapies. In this concise review, we examine the emergence of unproven CBIs and the various policy approaches that have been pursued or proposed to address this problem. We review the evolution of this field over the last 2 decades and explore why these policy efforts have proven challenging. We conclude by highlighting potential directions that the field could evolve and urging continued attention to both current and future forms of unproven CBIs to minimize future risks to patients and the field and to promote the development of evidence-based cell therapies.
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Affiliation(s)
- Taylor N Brinsfield
- School of Public Policy, Georgia Institute of Technology, Atlanta, GA 30332-0345, United States
| | - Noah R Pinson
- School of Public Policy, Georgia Institute of Technology, Atlanta, GA 30332-0345, United States
| | - Aaron D Levine
- School of Public Policy, Georgia Institute of Technology, Atlanta, GA 30332-0345, United States
- Petit Institute for Bioengineering and Bioscience, Georgia Institute of Technology, Atlanta, GA 30332-0363, United States
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7
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Iem D, Carney G, Munsie M, Nayagam BA. Towards stem cell therapies for hearing loss: awareness and perspectives of Australian audiologists and their patients. Regen Med 2024; 19:483-496. [PMID: 39378073 PMCID: PMC11487944 DOI: 10.1080/17460751.2024.2402650] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2024] [Accepted: 09/06/2024] [Indexed: 10/20/2024] Open
Abstract
Aim: Over the last two decades, numerous experimental studies have examined the feasibility of delivering stem cells into the cochlea to restore hearing. While these studies have spawned new cell therapy companies, there is little information on what patients understand or expect from these emerging therapies.Methods: This study sought to understand the awareness and perspectives of Australian audiologists and their adult patients toward stem cell therapies for treating hearing loss.Results: An anonymous survey indicated 91% of patients and 39% of audiologists were unaware of these therapies being developed. Thirty percent of audiologists reported being asked about stem cell therapies for hearing loss, but 70% were not confident answering patient queries about this and were unsure where to gather information. Primary concerns reported by patients were cost (45%) and safety of treatment (42%). Interestingly, 58% of patients were unsure of how this therapy would improve their hearing, yet 25% of these patients expected that their hearing would return to normal.Conclusion: There was strong support for development of educational materials for both patient and clinician. The increasingly important role of audiologists in providing patient counselling was reflected in overwhelming support (from both patient and clinician) for audiologists providing such information.
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Affiliation(s)
- Dysiphan Iem
- Department of Audiology & Speech Pathology, University of Melbourne, 3010, Australia
| | - Georgia Carney
- Department of Audiology & Speech Pathology, University of Melbourne, 3010, Australia
| | - Megan Munsie
- Murdoch Children's Research Institute, Melbourne, 3052, Australia
- Department of Medicine, University of Melbourne, 3010, Australia
| | - Bryony A Nayagam
- Department of Audiology & Speech Pathology, University of Melbourne, 3010, Australia
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8
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Ogbogu U, Case N. Clinical use of autologous cell-based therapies in an evolving regulatory landscape: A survey of patient experiences and perceptions. F1000Res 2024; 12:1165. [PMID: 39430869 PMCID: PMC11489844 DOI: 10.12688/f1000research.141002.2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 08/20/2024] [Indexed: 10/22/2024] Open
Abstract
Background: Clinical treatments involving autologous cell-based therapies (ACBT) remain prevalent despite a lack of scientific backing and an evolving regulatory landscape aimed at assessing their safety and efficacy for clinical adoption. This study seeks to assess patients' experiences and perceptions of clinical treatments involving ACBT and their knowledge and views of the regulatory context and associated governance issues. Methods: An anonymous online survey of 181 participants who have been treated or are in the process of being treated with ACBT was conducted. Recruitment was via social media platforms. Data was collected through Qualtrics and analyzed using SPSS 29 for the quantitative responses and NVivo 1.7.1 for the qualitative responses. Results: Several themes emerged from the data, including the prominent role of healthcare providers throughout the patient journey, informational practices during the clinical encounter, the high prevalence of pay-for-participation trials, patients' gaps in regulatory knowledge, and patients' priorities regarding clinical trials and regulation of ACBT. Conclusions: The study makes a novel contribution to the literature by providing the first analysis of patients' experiences and perceptions of an emerging cell-based therapy within an evolving regulatory landscape. The findings serve as a valuable resource for developing policy, promoting scientific rigor, and ensuring ethical oversight of ACBT and other upcoming cell-based therapies.
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Affiliation(s)
- Ubaka Ogbogu
- Faculty of Law, University of Alberta, Edmonton, Alberta, T6G2H5, Canada
| | - Nevicia Case
- Faculty of Law, University of Alberta, Edmonton, Alberta, T6G2H5, Canada
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Ruoss S, Nasamran CA, Ball ST, Chen JL, Halter KN, Bruno KA, Whisenant TC, Parekh JN, Dorn SN, Esparza MC, Bremner SN, Fisch KM, Engler AJ, Ward SR. Comparative single-cell transcriptional and proteomic atlas of clinical-grade injectable mesenchymal source tissues. SCIENCE ADVANCES 2024; 10:eadn2831. [PMID: 38996032 PMCID: PMC11244553 DOI: 10.1126/sciadv.adn2831] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/01/2023] [Accepted: 06/06/2024] [Indexed: 07/14/2024]
Abstract
Bone marrow aspirate concentrate (BMAC) and adipose-derived stromal vascular fraction (ADSVF) are the most marketed stem cell therapies to treat a variety of conditions in the general population and elite athletes. Both tissues have been used interchangeably clinically even though their detailed composition, heterogeneity, and mechanisms of action have neither been rigorously inventoried nor compared. This lack of information has prevented investigations into ideal dosages and has facilitated anecdata and misinformation. Here, we analyzed single-cell transcriptomes, proteomes, and flow cytometry profiles from paired clinical-grade BMAC and ADSVF. This comparative transcriptional atlas challenges the prevalent notion that there is one therapeutic cell type present in both tissues. We also provide data of surface markers that may enable isolation and investigation of cell (sub)populations. Furthermore, the proteome atlas highlights intertissue and interpatient heterogeneity of injected proteins with potentially regenerative or immunomodulatory capacities. An interactive webtool is available online.
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Affiliation(s)
- Severin Ruoss
- Department of Orthopaedic Surgery, UC San Diego, La Jolla, CA, USA
| | - Chanond A. Nasamran
- Center for Computational Biology and Bioinformatics, UC San Diego, La Jolla, CA, USA
| | - Scott T. Ball
- Department of Orthopaedic Surgery, UC San Diego, La Jolla, CA, USA
| | - Jeffrey L. Chen
- Department of Anesthesiology, Center for Pain, UC San Diego, La Jolla, CA, USA
| | - Kenneth N. Halter
- Department of Anesthesiology, Center for Pain, UC San Diego, La Jolla, CA, USA
| | - Kelly A. Bruno
- Department of Anesthesiology, Center for Pain, UC San Diego, La Jolla, CA, USA
| | - Thomas C. Whisenant
- Center for Computational Biology and Bioinformatics, UC San Diego, La Jolla, CA, USA
| | - Jesal N. Parekh
- Department of Orthopaedic Surgery, UC San Diego, La Jolla, CA, USA
| | - Shanelle N. Dorn
- Department of Orthopaedic Surgery, UC San Diego, La Jolla, CA, USA
| | - Mary C. Esparza
- Department of Orthopaedic Surgery, UC San Diego, La Jolla, CA, USA
| | | | - Kathleen M. Fisch
- Center for Computational Biology and Bioinformatics, UC San Diego, La Jolla, CA, USA
- Department of Obstetrics, Gynecology & Reproductive Sciences, UC San Diego, La Jolla, CA, USA
| | - Adam J. Engler
- Chien-Lay Department of Bioengineering, UC San Diego, La Jolla, CA, USA
- Sanford Consortium for Regenerative Medicine, La Jolla, CA, USA
| | - Samuel R. Ward
- Department of Orthopaedic Surgery, UC San Diego, La Jolla, CA, USA
- Chien-Lay Department of Bioengineering, UC San Diego, La Jolla, CA, USA
- Department of Radiology, UC San Diego, La Jolla, CA, USA
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10
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Perez AM, Chau VQ, Sridhar J. Medical Accuracy of Reddit in Patient Discussions of Prospective Ocular Stem Cell Therapies for Retinal Degenerative Diseases. JOURNAL OF VITREORETINAL DISEASES 2024; 8:410-414. [PMID: 39148570 PMCID: PMC11323517 DOI: 10.1177/24741264241246317] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 08/17/2024]
Abstract
Purpose: To evaluate the medical accuracy in discussions of stem cell therapy for retinal diseases on a social media internet forum (Reddit). Methods: A cross-sectional study assessed 11 Reddit forums and 411 unique comments from 2017 to 2022. Evaluated participants were all anonymous Reddit users. Discussions were independently examined for medical accuracy by a board-certified, fellowship-trained retina surgeon in active practice. Results: Reddit users self-identified mainly as prospective patients followed by research students and physicians or healthcare workers. Inquiries mostly regarded stem cell treatment for macular degeneration. Thirty-six percent of the forum's content was found to be inaccurate or misleading. When specifically considering factual comments, the inaccuracy rate increased to 54%. Identified gaps in knowledge mostly regarded the current state of the technology (25%) followed by misinterpretation of trial results (16%) and scam treatments (14%). Most inaccurate or misleading comments favored stem cell advancements (72%). Conclusions: This study highlights the gaps in knowledge and areas of medical misinformation regarding ocular stem cell therapies shared by individuals on Reddit.
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Affiliation(s)
- Alejandro M. Perez
- Herbert Wertheim College of Medicine, Florida International University, Miami, FL, USA
| | - Viet Q. Chau
- Department of Ophthalmology, University of Miami Health System, Bascom Palmer Eye Institute, Miami, FL, USA
| | - Jayanth Sridhar
- Department of Ophthalmology, University of Miami Health System, Bascom Palmer Eye Institute, Miami, FL, USA
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11
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Turner L, Wang JC, Martinez JR, Najjar S, Rajapaksha Arachchilage T, Sahrai V. US businesses engaged in direct-to-consumer marketing of perinatal stem cell interventions following the Food and Drug Administration's enforcement discretion era. Cytotherapy 2024; 26:393-403. [PMID: 38340106 DOI: 10.1016/j.jcyt.2024.01.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/13/2023] [Revised: 12/19/2023] [Accepted: 01/04/2024] [Indexed: 02/12/2024]
Abstract
BACKGROUND AIMS The goal of this study was to analyze online marketing representations made by 300 US businesses selling allogeneic perinatal stem cell products. The study was conducted after a period of enforcement discretion by the US Food and Drug Administration (FDA). METHODS Data mining and content analysis were used to identify, analyze and categorize marketing claims made on the websites of 300 businesses selling perinatal stem cell interventions. RESULTS The study identified types of perinatal interventions companies advertised, geographic locations of clinics selling such products, types of companies operating in this space, diseases and injuries such businesses claim to treat, prices companies charge for such interventions, brand names of advertised perinatal cell products and identities of suppliers. CONCLUSIONS A substantial number of US businesses market unapproved perinatal stem cell products for various indications. This widespread commercial activity occurred following the conclusion of a period of enforcement discretion by the FDA and suggests the need for more robust and comprehensive regulatory responses to businesses selling unapproved perinatal stem cell products.
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Affiliation(s)
- Leigh Turner
- Program in Public Health, University of California Irvine, Irvine, California, USA; Department of Health, Society and Behavior, University of California Irvine, Irvine, California, USA; Sue and Bill Gross Stem Cell Research Center, University of California Irvine, Irvine, California, USA; Department of Family Medicine, University of California Irvine, Irvine, California, USA.
| | - Jia Chieng Wang
- Program in Public Health, University of California Irvine, Irvine, California, USA
| | - Juan Ramon Martinez
- Program in Public Health, University of California Irvine, Irvine, California, USA
| | - Shemms Najjar
- Program in Public Health, University of California Irvine, Irvine, California, USA
| | | | - Victoria Sahrai
- Program in Public Health, University of California Irvine, Irvine, California, USA
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12
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Hoeyer K, Couturier A, Barawi K, Drew C, Grundtvig A, Lane E, Munk AK, Whiteley LE, Munsie M. Searching for information about stem cells online in an age of artificial intelligence: How should the stem cell community respond? Stem Cell Reports 2024; 19:159-162. [PMID: 38278153 PMCID: PMC10874854 DOI: 10.1016/j.stemcr.2023.12.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/15/2023] [Revised: 12/18/2023] [Accepted: 12/20/2023] [Indexed: 01/28/2024] Open
Abstract
Patients and their families routinely use the Internet to learn about stem cell research. What they find, is increasingly influenced by ongoing changes in how information is filtered and presented online. This article reflects on recent developments in generative artificial intelligence and how the stem cell community should respond.
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Affiliation(s)
- Klaus Hoeyer
- Department of Public Health, University of Copenhagen, Copenhagen, Denmark
| | | | - Kali Barawi
- Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK
| | - Cheney Drew
- Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK
| | - Anders Grundtvig
- Department of Public Health, University of Copenhagen, Copenhagen, Denmark
| | - Emma Lane
- School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, UK
| | - Anders Kristian Munk
- TANTlab, Department of Culture and Learning, Aalborg University, Aalborg, Denmark
| | | | - Megan Munsie
- Stem Cell Biology Theme, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.
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Turner L, Martinez JR, Najjar S, Arachchilage TR, Sahrai V, Wang JC. Regulatory claims made by US businesses engaged in direct-to-consumer marketing of purported stem cell treatments and exosome therapies. Regen Med 2023; 18:857-868. [PMID: 37867326 DOI: 10.2217/rme-2023-0117] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/24/2023] Open
Abstract
Aim: This study investigated whether US businesses engaged in direct-to-consumer online marketing of purported stem cell therapies and stem cell-derived exosome products made claims concerning the regulatory status of these interventions. Methods: We used data mining and content analysis of company websites to examine regulatory-related representations made by US businesses marketing stem cell treatments and exosome therapies. Results: More than two thirds of such businesses did not make explicit representations about the regulatory status of their marketed products. Businesses that made claims about the regulatory status of the stem cell and exosome products they sold used range of representations concerning the legal standing of these interventions. Conclusion: The absence of information addressing the regulatory status of stem cell interventions and exosome products and the use of what appeared to be inaccurate information concerning the regulatory status of numerous products likely complicates efforts by customers to make informed health-related decisions.
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Affiliation(s)
- Leigh Turner
- Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Room 3543, Irvine, CA 92697-3957, USA
- Department of Health, Society, & Behavior, University of California Irvine, Irvine, CA 92697-3957, USA
- Sue & Bill Gross Stem Cell Research Center, University of California, Irvine, CA 92697-3957, USA
| | - Juan Ramon Martinez
- Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Room 3543, Irvine, CA 92697-3957, USA
| | - Shemms Najjar
- Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Room 3543, Irvine, CA 92697-3957, USA
| | - Thevin Rajapaksha Arachchilage
- Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Room 3543, Irvine, CA 92697-3957, USA
| | - Victoria Sahrai
- Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Room 3543, Irvine, CA 92697-3957, USA
| | - Jia Chieng Wang
- Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Room 3543, Irvine, CA 92697-3957, USA
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14
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Turner L, Martinez JR, Najjar S, Arachchilage TR, Sahrai V, Wang JC. Safety and efficacy claims made by US businesses marketing purported stem cell treatments and exosome therapies. Regen Med 2023; 18:781-793. [PMID: 37795701 DOI: 10.2217/rme-2023-0118] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/06/2023] Open
Abstract
Aim: Examining websites of US businesses engaged in direct-to-consumer advertising of putative stem cell treatments and exosome therapies, this study investigated the marketing claims such companies make about the purported safety and efficacy of these products. Methods: Data mining and content analysis of company websites were used to identify and analyze safety and efficacy claims. Results: Of the 978 businesses analyzed, less than half the companies made identifiable claims about the safety and efficacy of their advertised stem cell and exosome products. We also explored how companies framed the stem cell and exosome products they promoted. Representations ranged from assertions that such products are unproven and investigational to claims they constituted cures. Most advertising frames fell between these poles. Conclusion: Some businesses include in their marketing representations claims about the safety and efficacy of advertised products. Businesses that did not make such assertions use other techniques to attract prospective clients.
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Affiliation(s)
- Leigh Turner
- Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Irvine, CA 92697-3957, USA
- Department of Health, Society, & Behavior, University of California, Irvine, CA 92697-3957, USA
- Sue & Bill Gross Stem Cell Research Center, University of California, Irvine, CA 92697, USA
| | - Juan Ramon Martinez
- Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Irvine, CA 92697-3957, USA
| | - Shemms Najjar
- Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Irvine, CA 92697-3957, USA
| | - Thevin Rajapaksha Arachchilage
- Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Irvine, CA 92697-3957, USA
| | - Victoria Sahrai
- Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Irvine, CA 92697-3957, USA
| | - Jia Chieng Wang
- Program in Public Health, University of California Irvine, UCI Health Sciences Complex, 856 Health Sciences Quad, Irvine, CA 92697-3957, USA
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15
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Lee EY, Spinner RJ, Mortazavi MM, Angius D, Adeeb N, Bishop AT, Shin AY. Stem cell therapy for traumatic brachial plexus injury. Acta Neurochir (Wien) 2023; 165:2011-2014. [PMID: 37389748 DOI: 10.1007/s00701-023-05675-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/22/2023] [Accepted: 06/06/2023] [Indexed: 07/01/2023]
Abstract
Stem cell therapy is rapidly evolving, with preclinical studies showing various stem cell types successfully promoting peripheral nerve regeneration. Despite the lack of clinical studies demonstrating efficacy and safety, the number of commercial entities marketing and promoting this treatment direct to patients is also increasing. We describe three adult traumatic brachial plexus injury (BPI) patients who had stem cell therapies prior to consultation in a multidisciplinary brachial plexus clinic. No functional improvement was noted at long-term follow-up despite claims reported by the commercial entities. Considerations and implications of stem cell application in BPI patients are reviewed.
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Affiliation(s)
- Ellen Y Lee
- Department of Orthopedic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA
- Department of Hand and Reconstructive Microsurgery, National University Health System, Singapore, 119228, Singapore
| | - Robert J Spinner
- Department of Neurosurgery, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA
| | - Martin M Mortazavi
- California Institute of Neuroscience, 2100 Lynn Rd, Suite 120, Thousand Oaks, CA, 91360, USA
| | - Diana Angius
- Fondazione Don Gnocchi, Piazza Castello 20-22, 20060 Pessano con Bornago, Milan, Italy
| | - Nimer Adeeb
- Department of Neurosurgery, Louisiana State University, Shreveport, LA, 71103, USA
| | - Allen T Bishop
- Department of Orthopedic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA
| | - Alexander Y Shin
- Department of Orthopedic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.
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16
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Asadpour A, Yahaya BH, Bicknell K, Cottrell GS, Widera D. Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes. Stem Cell Res Ther 2023; 14:111. [PMID: 37138298 PMCID: PMC10156419 DOI: 10.1186/s13287-023-03335-2] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/07/2022] [Accepted: 04/10/2023] [Indexed: 05/05/2023] Open
Abstract
BACKGROUND The last decade has seen a significant increase in media attention, industrial growth, and patient interest in stem cell-based interventions. This led to a rise in direct-to-consumer businesses offering stem cell "therapies" for multiple indications with little evidence of safety and efficacy. In parallel, the use of stem cell secretomes as a substitute for stem cell transplantation has become an increasing trend in regenerative medicine with multiple clinical trials currently assessing their efficacy and safety profile. As a result, multiple businesses and private clinics have now started to exploit this situation and are offering secretome-based interventions despite the lack of supporting data. This poses significant risks for the patients and could lead to a credibility crisis in the field. METHODS Internet searches were used to locate clinics marketing and selling interventions based on stem cell secretomes, exosomes, or extracellular vesicles. Data were extracted from websites with a particular focus on the global distribution of the businesses, the cellular source of the secretome, the indication spectrum, and the pricing of the provided services. Lastly, the types of evidence used on the websites of the businesses to market their services were extracted. RESULTS Overall, 114 companies market secretome-based therapies in 28 countries. The vast majority of the interventions are based on allogenic stem cells from undisclosed cellular sources and skin care is the most marketed indication. The price range is USD99-20,000 depending on the indication. CONCLUSIONS The direct-to-consumer industry for secretome-based therapies appears to be primed for growth in the absence of appropriate regulatory frameworks and guidelines. We conclude that such business activity requires tight regulations and monitoring by the respective national regulatory bodies to prevent patients from being conned and more importantly from being put at risk.
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Affiliation(s)
- Atiyeh Asadpour
- Stem Cell Biology and Regenerative Medicine Group, School of Pharmacy, University of Reading, PO Box 226, Whiteknights, Reading, RG6 6AP, UK
| | - Badrul Hisham Yahaya
- Lung Stem Cell and Gene Therapy Group, Department of Biomedical Sciences, Advanced Medical and Dental Institute (IPPT), Universiti Sains Malaysia, Sains@Bertam, 13200, Kepala Batas, Penang, Malaysia
| | - Katrina Bicknell
- School of Pharmacy, University of Reading, PO Box 226, Whiteknights, Reading, RG6 6AP, UK
| | - Graeme S Cottrell
- Cellular and Molecular Neuroscience, School of Pharmacy, University of Reading, PO Box 226, Whiteknights, Reading, RG6 6AP, UK
| | - Darius Widera
- Stem Cell Biology and Regenerative Medicine Group, School of Pharmacy, University of Reading, PO Box 226, Whiteknights, Reading, RG6 6AP, UK.
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17
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Regulatory Considerations of Orthobiologic Procedures. Phys Med Rehabil Clin N Am 2023; 34:275-283. [DOI: 10.1016/j.pmr.2022.08.016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/19/2022]
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18
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Karimy JK, Newville JC, Sadegh C, Morris JA, Monuki ES, Limbrick DD, McAllister Ii JP, Koschnitzky JE, Lehtinen MK, Jantzie LL. Outcomes of the 2019 hydrocephalus association workshop, "Driving common pathways: extending insights from posthemorrhagic hydrocephalus". Fluids Barriers CNS 2023; 20:4. [PMID: 36639792 PMCID: PMC9838022 DOI: 10.1186/s12987-023-00406-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/19/2022] [Accepted: 01/05/2023] [Indexed: 01/15/2023] Open
Abstract
The Hydrocephalus Association (HA) workshop, Driving Common Pathways: Extending Insights from Posthemorrhagic Hydrocephalus, was held on November 4 and 5, 2019 at Washington University in St. Louis. The workshop brought together a diverse group of basic, translational, and clinical scientists conducting research on multiple hydrocephalus etiologies with select outside researchers. The main goals of the workshop were to explore areas of potential overlap between hydrocephalus etiologies and identify drug targets that could positively impact various forms of hydrocephalus. This report details the major themes of the workshop and the research presented on three cell types that are targets for new hydrocephalus interventions: choroid plexus epithelial cells, ventricular ependymal cells, and immune cells (macrophages and microglia).
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Affiliation(s)
- Jason K Karimy
- Department of Family Medicine, Mountain Area Health Education Center - Boone, North Carolina, 28607, USA
| | - Jessie C Newville
- Department of Pediatrics and Neurosurgery, Johns Hopkins Children's Center, Johns Hopkins School of Medicine, Baltimore, MD, 21287, USA
| | - Cameron Sadegh
- Department of Neurosurgery, Massachusetts General Hospital and Harvard Medical School, MA, Boston, 02114, USA
- Department of Pathology, Boston Children's Hospital, Boston, MA, 02115, USA
| | - Jill A Morris
- National Institute of Neurological Disorders and Stroke, Neuroscience Center, National Institutes of Health, 6001 Executive Blvd, NSC Rm 2112, Bethesda, MD, 20892, USA
| | - Edwin S Monuki
- Departments of Pathology & Laboratory Medicine and Developmental & Cell Biology, University of California Irvine, Irvine, CA, 92697, USA
| | - David D Limbrick
- Departments of Neurosurgery and Pediatrics, Washington University School of Medicine in St. Louis, St. Louis, MO, 63110, USA
| | - James P McAllister Ii
- Departments of Neurosurgery and Pediatrics, Washington University School of Medicine in St. Louis, St. Louis, MO, 63110, USA
| | | | - Maria K Lehtinen
- Department of Pathology, Boston Children's Hospital, Boston, MA, 02115, USA.
| | - Lauren L Jantzie
- Department of Pediatrics and Neurosurgery, Johns Hopkins Children's Center, Johns Hopkins School of Medicine, Baltimore, MD, 21287, USA.
- Kennedy Krieger Institute, Baltimore, MD, 21287, USA.
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19
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Fujita M, Hatta T, Ide K. Current status of cell-based interventions in Japan. Cell Stem Cell 2022; 29:1294-1297. [PMID: 36055190 DOI: 10.1016/j.stem.2022.08.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/14/2022] [Revised: 06/02/2022] [Accepted: 08/08/2022] [Indexed: 11/25/2022]
Abstract
The Act on the Safety of Regenerative Medicine regulates cell-based interventions in Japan. Recent revisions to the law require disclosure of explanatory and consent materials for interventions seeking approval. In this Forum, we present an updated analysis of the status and challenges facing the Japanese regulatory framework.
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Affiliation(s)
- Misao Fujita
- Uehiro Research Division for iPS Cell Ethics, Center for iPS Cell Research and Application (CiRA), Kyoto University, Sakyo-ku, Kyoto 606-8507, Japan; Institute for the Advanced Study of Human Biology (WPI-ASHBi), KUIAS, Kyoto University, Sakyo-ku, Kyoto 606-8501, Japan.
| | - Taichi Hatta
- Graduate School of Public Health, Shizuoka Graduate University of Public Health, Aoi-ku, Shizuoka 420-0881, Japan
| | - Kazuki Ide
- Division of Scientific Information and Public Policy, Center for Infectious Disease Education and Research, Osaka University, Suita, Osaka 565-0871, Japan; Research Center on Ethical, Legal and Social Issues, Osaka University, Suita, Osaka 565-0871, Japan
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20
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Zhang X, Wang D, Wang Z, Ling SKK, Yung PSH, Tuan RS, Ker DFE. Clinical perspectives for repairing rotator cuff injuries with multi-tissue regenerative approaches. J Orthop Translat 2022; 36:91-108. [PMID: 36090820 PMCID: PMC9428729 DOI: 10.1016/j.jot.2022.06.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/22/2022] [Revised: 06/15/2022] [Accepted: 06/21/2022] [Indexed: 11/25/2022] Open
Abstract
Background In the musculoskeletal system, bone, tendon, and muscle form highly integrated multi-tissue units such as the rotator cuff complex, which facilitates functional and dynamic movement of the shoulder joint. Understanding the intricate interplay among these tissues within clinical, biological, and engineering contexts is vital for addressing challenging issues in treatment of musculoskeletal disorders and injuries. Methods A wide-ranging literature search was performed, and findings related to the socioeconomic impact of rotator cuff tears, the structure-function relationship of rotator cuff bone-tendon-muscle units, pathophysiology of injury, current clinical treatments, recent state-of-the-art advances (stem cells, growth factors, and exosomes) as well as their regulatory approval, and future strategies aimed at engineering bone-tendon-muscle musculoskeletal units are outlined. Results Rotator cuff injuries are a significant socioeconomic burden on numerous healthcare systems that may be addressed by treating the rotator cuff as a single complex, given its highly integrated structure-function relationship as well as degenerative pathophysiology and limited healing in bone-tendon-muscle musculoskeletal tissues. Current clinical practices for treating rotator cuff injuries, including the use of commercially available devices and evolving trends in surgical management have benefited patients while advances in application of stem/progenitor cells, growth factors, and exosomes hold clinical potential. However, such efforts do not emphasize targeted regeneration of bone-tendon-muscle units. Strategies aimed at regenerating bone-tendon-muscle units are thus expected to address challenging issues in rotator cuff repair. Conclusions The rotator cuff is a highly integrated complex of bone-tendon-muscle units that when injured, has severe consequences for patients and healthcare systems. State-of-the-art clinical treatment as well as recent advances have resulted in improved patient outcome and may be further enhanced by engineering bone-tendon-muscle multi-tissue grafts as a potential strategy for rotator cuff injuries. Translational Potential of this Article This review aims to bridge clinical, tissue engineering, and biological aspects of rotator cuff repair and propose a novel therapeutic strategy by targeted regeneration of multi-tissue units. The presentation of these wide-ranging and multi-disciplinary concepts are broadly applicable to regenerative medicine applications for musculoskeletal and non-musculoskeletal tissues.
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Affiliation(s)
- Xu Zhang
- Institute for Tissue Engineering and Regenerative Medicine, Hong Kong
- School of Biomedical Sciences, Hong Kong
| | - Dan Wang
- Institute for Tissue Engineering and Regenerative Medicine, Hong Kong
- School of Biomedical Sciences, Hong Kong
- Ministry of Education Key Laboratory for Regenerative Medicine, School of Biomedical Sciences, Hong Kong
- Department of Orthopaedics and Traumatology, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
- Center for Neuromusculoskeletal Restorative Medicine, Hong Kong Science Park, Hong Kong
| | - Zuyong Wang
- College of Materials Science and Engineering, Hunan University, Changsha, China
| | - Samuel Ka-kin Ling
- Department of Orthopaedics and Traumatology, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
- Center for Neuromusculoskeletal Restorative Medicine, Hong Kong Science Park, Hong Kong
| | - Patrick Shu-hang Yung
- Department of Orthopaedics and Traumatology, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
- Center for Neuromusculoskeletal Restorative Medicine, Hong Kong Science Park, Hong Kong
| | - Rocky S. Tuan
- Institute for Tissue Engineering and Regenerative Medicine, Hong Kong
- School of Biomedical Sciences, Hong Kong
- Center for Neuromusculoskeletal Restorative Medicine, Hong Kong Science Park, Hong Kong
| | - Dai Fei Elmer Ker
- Institute for Tissue Engineering and Regenerative Medicine, Hong Kong
- School of Biomedical Sciences, Hong Kong
- Ministry of Education Key Laboratory for Regenerative Medicine, School of Biomedical Sciences, Hong Kong
- Department of Orthopaedics and Traumatology, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
- Center for Neuromusculoskeletal Restorative Medicine, Hong Kong Science Park, Hong Kong
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21
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Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products. Cytotherapy 2022; 24:686-690. [DOI: 10.1016/j.jcyt.2022.03.007] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2021] [Revised: 03/17/2022] [Accepted: 03/20/2022] [Indexed: 11/21/2022]
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22
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Financial risks posed by unproven cell interventions: Estimation of refunds from medical expense deductions in Japan. Stem Cell Reports 2022; 17:1016-1018. [PMID: 35452594 PMCID: PMC9133642 DOI: 10.1016/j.stemcr.2022.03.015] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/24/2021] [Revised: 03/16/2022] [Accepted: 03/22/2022] [Indexed: 11/22/2022] Open
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23
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Arthurs JR, Nordan LM, Hultgren BH, Heckman MG, Martinez D, Master Z, Shapiro SA. Patients seeking stem cell therapies-a prospective qualitative analysis from a Regenerative Medicine Consult Service. NPJ Regen Med 2022; 7:20. [PMID: 35338147 PMCID: PMC8956610 DOI: 10.1038/s41536-022-00215-w] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2021] [Accepted: 02/15/2022] [Indexed: 02/08/2023] Open
Abstract
Despite patient demand for stem cell therapies (SCTs) for musculoskeletal conditions, there remains limited research on why patients seek SCTs or their sources of information. We employ three questions into a consult intake form: (1) Why are you interested in stem cell treatment for your condition? (2) How did you find out about stem cell treatment for your condition? (3) Have you contacted a stem cell clinic? Responses analyzed, using a qualitative content analysis approach to identify themes reveal many patients seek SCTs to treat pain or delay surgery which may align with some current clinical evidence while other patients express motivations as expected outcomes (e.g., SCTs are better than standard of care or can regenerate tissue) which are not supported by current medical evidence. These differences suggests that patient-centered counseling may help patients by addressing misconceptions and increasing health literacy about expected outcomes of SCTs for treating musculoskeletal conditions.
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Affiliation(s)
| | - Lisa M Nordan
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Jacksonville, FL, USA
| | - Brian H Hultgren
- Center for Regenerative Medicine, Mayo Clinic, Jacksonville, FL, USA
| | - Michael G Heckman
- Division of Biomedical Statistics and Informatics, Mayo Clinic, Jacksonville, FL, USA
| | - Dayana Martinez
- United States Navy, Washington, DC, USA
- Center for Regenerative Medicine, Mayo Clinic, Jacksonville, FL, USA
| | - Zubin Master
- Biomedical Ethics Research Program and the Center for Regenerative Medicine, Mayo Clinic, Rochester, MN, USA.
| | - Shane A Shapiro
- Department of Orthopedic Surgery, Mayo Clinic, Jacksonville, FL, USA.
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24
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Cell models for Down syndrome-Alzheimer’s disease research. Neuronal Signal 2022; 6:NS20210054. [PMID: 35449591 PMCID: PMC8996251 DOI: 10.1042/ns20210054] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/27/2021] [Revised: 03/07/2022] [Accepted: 03/21/2022] [Indexed: 11/29/2022] Open
Abstract
Down syndrome (DS) is the most common chromosomal abnormality and leads to intellectual disability, increased risk of cardiac defects, and an altered immune response. Individuals with DS have an extra full or partial copy of chromosome 21 (trisomy 21) and are more likely to develop early-onset Alzheimer’s disease (AD) than the general population. Changes in expression of human chromosome 21 (Hsa21)-encoded genes, such as amyloid precursor protein (APP), play an important role in the pathogenesis of AD in DS (DS-AD). However, the mechanisms of DS-AD remain poorly understood. To date, several mouse models with an extra copy of genes syntenic to Hsa21 have been developed to characterise DS-AD-related phenotypes. Nonetheless, due to genetic and physiological differences between mouse and human, mouse models cannot faithfully recapitulate all features of DS-AD. Cells differentiated from human-induced pluripotent stem cells (iPSCs), isolated from individuals with genetic diseases, can be used to model disease-related cellular and molecular pathologies, including DS. In this review, we will discuss the limitations of mouse models of DS and how these can be addressed using recent advancements in modelling DS using human iPSCs and iPSC-mouse chimeras, and potential applications of iPSCs in preclinical studies for DS-AD.
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25
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Orozco-Solares TE, León-Moreno LC, Rojas-Rizo A, Manguart-Paez K, Caplan AI. Allogeneic Mesenchymal Stem Cell-based treatments legislation in Latin America: The need for standardization in a medical tourism context. Stem Cells Dev 2022; 31:143-162. [PMID: 35216516 DOI: 10.1089/scd.2022.0013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/12/2022] Open
Abstract
Medicinal Signaling Cells (MSCs) secrete bioactive molecules with paracrine effects. These cells are widely used in basic and clinical research to treat several human diseases and medically relevant conditions. Although there are promising results, only a few treatments are approved of its administration, and clinicians should not underestimate the potential risks of its application without proper authorization. However, some treatments advertised mainly through the internet are not supported by solid or rigorous scientific evidence, legal consent, or the assurance of safety and efficacy, especially in the cell therapy tourism space. This practice allows patients to travel from stringently regulated countries to less restricted ones and increases the flourishing of non-endorsed therapies in these regions. Clinical applications of MSC-based treatments are subject to health legislation, and regulatory agencies are responsible for supervising their manufacture, quality control, and marketing approval. Consensus is needed to homologize and strengthen health legislation regarding those therapies, particularly in regions where medical tourism is frequent. Latin America and the Caribbean, an overlooked region with very heterogeneous legislation regarding cell therapy, is a popular medical tourism destination. Brazil and Argentina created regulations to supervise cell-based treatments manufacture, quality, and marketing. While Mexico, considered the second-largest drug market in Latin America, does not recognize nor authorize any cells as therapy. Also, some regulatory bodies miss the importance of several critical GMP processes to ensure reproducible, reliable, safe, and potentially more favorable results and do not consider them in their legislation. These inconsistencies make the region vulnerable to unproven or unethical treatments, potentially becoming a public health problem involving people from countries worldwide. This review attempts to generate awareness for the legal status of cell therapies in Latin America and the need for standardization as this region is a significant medical tourism destination.
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Affiliation(s)
| | - Lilia Carolina León-Moreno
- Universidad de Guadalajara, 27802, Guadalajara, Jalisco, Mexico.,Provida Salud Integral, Research and Development, Guadalajara, Jalisco, Mexico;
| | - Andrea Rojas-Rizo
- Provida Salud Integral, Mesenchymal Stem Cell Bank, Guadalajara, Jalisco, Mexico;
| | - Karen Manguart-Paez
- Provida Salud Integral, Mesenchymal Stem Cell Bank, Guadalajara, Jalisco, Mexico;
| | - Arnold I Caplan
- Case Western Reserve University, 2546, Department of Biology, Cleveland, Ohio, United States;
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26
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Sukowati CHC, Tiribelli C. Adult Stem Cell Therapy as Regenerative Medicine for End-Stage Liver Disease. ADVANCES IN EXPERIMENTAL MEDICINE AND BIOLOGY 2022:57-72. [DOI: 10.1007/5584_2022_719] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
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Akkas F, Turner L, Richardson E. Adverse events related to unapproved stem cell products and other regenerative interventions: recommendations for more robust regulation of the direct-to-consumer marketplace. Regen Med 2021; 17:63-68. [PMID: 34927455 DOI: 10.2217/rme-2021-0124] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022] Open
Abstract
Tweetable abstract Adverse events continue to occur in the direct-to-consumer market for unapproved regenerative interventions and US FDA alone cannot adequately address the problem. Other public health strategies are needed to provide better patient protection.
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Affiliation(s)
- Farzana Akkas
- Senior Research Associate, Health Care Products Project, The Pew Charitable Trusts, 901 E Street NW, Washington, DC 20004, USA
| | - Leigh Turner
- Professor, Department of Health, Society & Behavior; Program in Public Health, Member, Stem Cell Research Center, University of California, Irvine, Anteater Instruction & Research Offices, 2nd Floor, 653 E. Peltason Dr., Irvine, CA 92697-3957, USA
| | - Elizabeth Richardson
- Director, Health Care Products Project, The Pew Charitable Trusts, 901 E Street NW, Washington, DC 20004, USA
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Bin Abdul Aziz MF, Morrison M, Kaye J. Creative regulatory practices to develop stem-cell technology: the way forward for Malaysia. Regen Med 2021; 17:91-105. [PMID: 34905952 DOI: 10.2217/rme-2021-0068] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022] Open
Abstract
Malaysia aspires to develop regenerative medicine through stem-cell technology. It needs a regulatory system that could facilitate development and prevent unethical practices. A comparative legal analysis on the regulation of stem-cell technology, with a focus on stem-cell research in Malaysia and selected Commonwealth countries that are experienced in regulating this complex technology, demonstrates that the selected Commonwealth countries have adopted a hybrid of different regulatory mechanisms. This paper argues that Malaysia should consider adopting a similar approach to equip relevant authorities with different regulatory mechanisms that are able to promote innovation in stem-cell research activities and cultivate a successful and profitable regenerative medicine industry in the future. Such a strategic action can produce an optimal regulatory outcome and help Malaysia to realize its aspiration.
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Affiliation(s)
- Mohammad Firdaus Bin Abdul Aziz
- Centre for Law and Ethics in Science and Technology (CELEST), Faculty of Law, Universiti Malaya, Kuala Lumpur, Malaysia.,Centre for Health, Law and Ethics of Emerging Technologies (HeLEX), Faculty of Law, University of Oxford, Oxford, United Kingdom
| | - Michael Morrison
- Centre for Health, Law and Ethics of Emerging Technologies (HeLEX), Faculty of Law, University of Oxford, Oxford, United Kingdom
| | - Jane Kaye
- Centre for Health, Law and Ethics of Emerging Technologies (HeLEX), Faculty of Law, University of Oxford, Oxford, United Kingdom
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29
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Smith C, Crowley A, Munsie M, Behfar A, DeMartino ES, Staff NP, Shapiro SA, Master Z. Academic Physician Specialists' Approaches to Counseling Patients Interested in Unproven Stem Cell and Regenerative Therapies-A Qualitative Analysis. Mayo Clin Proc 2021; 96:3086-3096. [PMID: 34454715 DOI: 10.1016/j.mayocp.2021.06.026] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/24/2021] [Revised: 05/26/2021] [Accepted: 06/25/2021] [Indexed: 11/16/2022]
Abstract
OBJECTIVE To explore the experiences, approaches, and challenges of physicians consulting patients about experimental stem cell and regenerative medicine interventions (SCRIs). PARTICIPANTS AND METHODS From August 21, 2018, through July 30, 2019, semistructured interviews of 25 specialists in cardiology, ophthalmology, orthopedics, pulmonology, and neurology were conducted and qualitatively analyzed using modified grounded theory. RESULTS All specialists used informational approaches to counsel patients, especially orthopedists. Informational approaches included explaining stem cell science, sharing risks, and providing principles. Several specialists also used relational counseling approaches including emphasizing that physicians want what is best for patients, acknowledging suffering, reassuring continued care, empathizing with patients and families, and underscoring that patients have the final decision. Many specialists reported being comfortable with the conversation, although some were less comfortable and several noted challenges in the consultation including wanting to support a patient's decision but worrying about harms from unproven SCRIs, navigating family pressure, and addressing stem cell hype and unrealistic expectations. Specialists also desired that additional resources be available for them and patients. CONCLUSION Physicians relied more heavily on providing patients with information about SCRIs than using relational counseling approaches. Efforts should be directed at helping physicians address the informational and relational needs of patients, including providing tools and resources that inform physicians about the unproven SCRI industry, building skills in empathic communication, and the creation and dissemination of evidence-based resources to offer patients.
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Affiliation(s)
- Cambray Smith
- University of North Carolina School of Medicine, Chapel Hill, NC
| | - Aidan Crowley
- Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
| | - Megan Munsie
- School of Biomedical Sciences and Melbourne Medical School, University of Melbourne, Parkville, Victoria, Australia
| | - Atta Behfar
- Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN; Center for Regenerative Medicine, Mayo Clinic, Rochester, MN
| | - Erin S DeMartino
- Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN; Biomedical Ethics Research Program, Mayo Clinic, Rochester, MN
| | | | - Shane A Shapiro
- Department of Orthopedic Surgery and Center for Regenerative Medicine, Mayo Clinic, Jacksonville, FL
| | - Zubin Master
- Center for Regenerative Medicine, Mayo Clinic, Rochester, MN; Biomedical Ethics Research Program, Mayo Clinic, Rochester, MN.
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Abstract
Aim: Explore the nature and extent of web-based promotion of stem cell treatments marketed by clinics in the UK. Materials & methods: Web-based analysis of clinics in the UK using predefined variables, with analysis of eligible clinics according to preset criteria of ethical relevance. Results: A majority (79%) of UK clinics were judged to be problematic. Information was found to be lacking, misleading or otherwise problematic in several respects, including a lack of information on risks of adverse effects, unjustifiably optimistic depictions of therapeutic effectiveness, and questionable presentational approaches such as the use of celebrity patient testimonials. Conclusion: In a majority of cases, commercial clinics in the UK portray stem-cell therapies on their websites in ethically questionable ways.
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Affiliation(s)
- Sami Kamel
- Division of Health Science, School of Applied Sciences, Abertay University, Dundee, DD1 1HG, UK
| | - Kevin R Smith
- Division of Health Science, School of Applied Sciences, Abertay University, Dundee, DD1 1HG, UK
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31
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Turner L. The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions. Cell Stem Cell 2021; 28:1891-1895. [PMID: 34739831 DOI: 10.1016/j.stem.2021.10.008] [Citation(s) in RCA: 19] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/11/2021] [Revised: 10/14/2021] [Accepted: 10/15/2021] [Indexed: 01/28/2023]
Abstract
In March 2021, 1,480 U.S. businesses operating 2,754 clinics were found selling purported stem cell treatments for various indications. More than four times as many businesses than were identified 5 years ago are selling stem cell products that are not FDA-approved and lack convincing evidence of safety and efficacy.
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Affiliation(s)
- Leigh Turner
- Department of Health, Society, and Behavior, Program in Public Health, Stem Cell Research Center, Institute for Clinical & Translational Science, University of California, Irvine, AIRB, 653 E. Peltason Drive, Room 2034, Irvine, CA 92697-3957, USA.
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32
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German OL, Vallese-Maurizi H, Soto TB, Rotstein NP, Politi LE. Retina stem cells, hopes and obstacles. World J Stem Cells 2021; 13:1446-1479. [PMID: 34786153 PMCID: PMC8567457 DOI: 10.4252/wjsc.v13.i10.1446] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/28/2021] [Revised: 07/14/2021] [Accepted: 09/17/2021] [Indexed: 02/07/2023] Open
Abstract
Retinal degeneration is a major contributor to visual dysfunction worldwide. Although it comprises several eye diseases, loss of retinal pigment epithelial (RPE) and photoreceptor cells are the major contributors to their pathogenesis. Early therapies included diverse treatments, such as provision of anti-vascular endothelial growth factor and many survival and trophic factors that, in some cases, slow down the progression of the degeneration, but do not effectively prevent it. The finding of stem cells (SC) in the eye has led to the proposal of cell replacement strategies for retina degeneration. Therapies using different types of SC, such as retinal progenitor cells (RPCs), embryonic SC, pluripotent SCs (PSCs), induced PSCs (iPSCs), and mesenchymal stromal cells, capable of self-renewal and of differentiating into multiple cell types, have gained ample support. Numerous preclinical studies have assessed transplantation of SC in animal models, with encouraging results. The aim of this work is to revise the different preclinical and clinical approaches, analyzing the SC type used, their efficacy, safety, cell attachment and integration, absence of tumor formation and immunorejection, in order to establish which were the most relevant and successful. In addition, we examine the questions and concerns still open in the field. The data demonstrate the existence of two main approaches, aimed at replacing either RPE cells or photoreceptors. Emerging evidence suggests that RPCs and iPSC are the best candidates, presenting no ethical concerns and a low risk of immunorejection. Clinical trials have already supported the safety and efficacy of SC treatments. Serious concerns are pending, such as the risk of tumor formation, lack of attachment or integration of transplanted cells into host retinas, immunorejection, cell death, and also ethical. However, the amazing progress in the field in the last few years makes it possible to envisage safe and effective treatments to restore vision loss in a near future.
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Affiliation(s)
- Olga L German
- Department of Biology, Biochemistry and Pharmacy, Universidad Nacional del Sur, Bahia blanca 8000, Buenos Aires, Argentina
- Department of Biology, Biochemistry and Pharmacy, Universidad Nacional del Sur, and Neurobiology Department, Instituto de Investigaciones Bioquímicas de Bahía Blanca (INIBIBB) Conicet, Bahía Blanca 8000, Buenos Aires, Argentina
| | - Harmonie Vallese-Maurizi
- Department of Biology, Biochemistry and Pharmacy, Universidad Nacional del Sur, Bahia blanca 8000, Buenos Aires, Argentina
- Department of Biology, Biochemistry and Pharmacy, Universidad Nacional del Sur, and Neurobiology Department, Instituto de Investigaciones Bioquímicas de Bahía Blanca (INIBIBB) Conicet, Bahía Blanca 8000, Buenos Aires, Argentina
| | - Tamara B Soto
- Department of Biology, Biochemistry and Pharmacy, Universidad Nacional del Sur, and Neurobiology Department, Instituto de Investigaciones Bioquímicas de Bahía Blanca (INIBIBB) Conicet, Bahía Blanca 8000, Buenos Aires, Argentina
| | - Nora P Rotstein
- Department of Biology, Biochemistry and Pharmacy, Universidad Nacional del Sur, Bahia blanca 8000, Buenos Aires, Argentina
- Department of Biology, Biochemistry and Pharmacy, Universidad Nacional del Sur, and Neurobiology Department, Instituto de Investigaciones Bioquímicas de Bahía Blanca (INIBIBB) Conicet, Bahía Blanca 8000, Buenos Aires, Argentina
| | - Luis Enrique Politi
- Department of Biology, Biochemistry and Pharmacy, Universidad Nacional del Sur, and Neurobiology Department, Instituto de Investigaciones Bioquímicas de Bahía Blanca (INIBIBB) Conicet, Bahía Blanca 8000, Buenos Aires, Argentina
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33
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Lyons S, Salgaonkar S, Flaherty GT. International stem cell tourism: a critical literature review and evidence-based recommendations. Int Health 2021; 14:132-141. [PMID: 34415026 PMCID: PMC8890798 DOI: 10.1093/inthealth/ihab050] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/16/2021] [Revised: 07/21/2021] [Accepted: 07/27/2021] [Indexed: 01/08/2023] Open
Abstract
Stem cell tourism is an emerging area of medical tourism activity. Frustrated by the slow translation of stem cell research into clinical practice, patients with debilitating conditions often seek therapeutic options that are not appropriately regulated. This review summarises recent developments in the field of stem cell tourism and provides clinicians with the information necessary to provide basic pretravel health advice to stem cell tourists. PubMed and Scopus databases were consulted for relevant publications, using combinations of the terms 'stem cell', 'tourism', 'regenerative medicine', 'international', 'travel medicine' and 'environmental health'. The leading countries in the international stem cell tourism market are the USA, China, India, Thailand and Mexico. As the majority of clinics offering stem cell therapies are based in low- and-middle-income countries, stem cell tourists place themselves at risk of receiving an unproven treatment, coupled with the risk of travel-related illnesses. These clinics do not generally provide even basic travel health information on their websites. In addition to often being ineffective, stem cell therapies are associated with complications such as infection, rejection and tumorigenesis. Physicians, researchers, regulatory bodies, advocacy groups and medical educators are encouraged to work together to improve patient and physician education and address current legislative deficiencies.
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Affiliation(s)
- Samantha Lyons
- School of Medicine, National University of Ireland Galway, Galway H91 TK33, Ireland.,Faculty of Health Sciences, University of Ottawa, Ontario, Canada
| | - Shival Salgaonkar
- School of Medicine, National University of Ireland Galway, Galway H91 TK33, Ireland
| | - Gerard T Flaherty
- School of Medicine, National University of Ireland Galway, Galway H91 TK33, Ireland.,School of Medicine, International Medical University, Kuala Lumpur, Malaysia
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34
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Rudge C, Ghinea N, Munsie M, Stewart C. Regulating autologous stem cell interventions in Australia: updated review of the direct-to-consumer advertising restrictions. AUST HEALTH REV 2021; 45:507-515. [PMID: 33952390 DOI: 10.1071/ah20217] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/21/2020] [Accepted: 11/11/2020] [Indexed: 11/23/2022]
Abstract
Objective This paper provides an update and overview of the law governing direct-to-consumer (DTC) advertising of autologous stem cell interventions (ASCIs) in Australia. It follows significant changes to the advertising regulations made in 2018. Methods The paper reviews the three primary sources or 'centres' of law regulating ASCIs in Australia, together with the relevant guidance documents that supplement these sources. It provides analysis of how the post-2018 advertising regulations, contained in the Therapeutic Goods Act 1989 (Cwlth), apply to all 'biologicals', including ASCIs. It demonstrates how these three sources of law interact with one another and outlines the new tiered offence regime that applies to contraventions of these prohibitions. Results The analysis demonstrates that DTC advertising of ASCIs in Australia is strictly controlled, with primary legislation prohibiting the advertising of biologicals altogether. Conclusions The polycentric legal regime regulating biologicals in Australia clearly makes DTC advertising of ASCIs unlawful. Health practitioners who promote ASCIs, either online, in print or in other media forms, may be penalised in different ways and by different authorities. What is known about the topic? Although several analyses have examined the regulation of ASCIs in Australia, no analysis has studied the reforms made in 2018 relating to the advertising of biologicals. As such, this analysis contributes a fresh examination of these relatively recent reforms. What does this paper add? This analysis clarifies the effects of these new advertising regulations, providing clear guidance on the relevant legal provisions for the benefit of health practitioners and health professionals more generally. What are the implications for practitioners? Health practitioners, especially those who offer ASCIs, should be aware that civil and criminal penalties are likely to be imposed on individuals who promote biologicals in Australia by any means.
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Affiliation(s)
- Chris Rudge
- Department of Anatomy and Neuroscience, The University of Melbourne, Victoria 3010, Australia. ; and Corresponding author.
| | - Narcyz Ghinea
- School of Public Health, Faculty of Medicine and Health, University of Sydney, NSW 2006, Australia.
| | - Megan Munsie
- Department of Anatomy and Neuroscience, The University of Melbourne, Victoria 3010, Australia.
| | - Cameron Stewart
- Faculty of Law, Rm No 337, New Law Building, University of Sydney, NSW 2006, Australia.
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35
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Takashima K, Morrison M, Minari J. Reflection on the enactment and impact of safety laws for regenerative medicine in Japan. Stem Cell Reports 2021; 16:1425-1434. [PMID: 34019814 PMCID: PMC8190593 DOI: 10.1016/j.stemcr.2021.04.017] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/25/2020] [Revised: 04/22/2021] [Accepted: 04/23/2021] [Indexed: 02/07/2023] Open
Abstract
Japan's Act on the Safety of Regenerative Medicine (ASRM) created an innovative regulatory framework intended to safely promote the clinical development of stem cell-based interventions (SCBIs) while subjecting commercialized unproven SCBIs to greater scrutiny and accountability. This article reviews ASRM's origins, explains its unprecedented scope, and assesses how it envisions the regulation of SCBIs. This analysis is used to highlight three key insights that are pertinent to the current revision of the ASRM: clarifying how the concept of safety should be defined and assessed in research and clinical care settings; revisiting risk criteria for review of SCBIs; and taking stronger measures to support the transition from unproven interventions to evidence-based therapies. Finally, the article reflects on lessons drawn from Japanese experiences in dealing with unproven SCBIs for international endeavors to regulate SCBIs.
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Affiliation(s)
- Kayo Takashima
- Uehiro Research Division of iPS Cell Ethics, Center for iPS Cell Research and Application, Kyoto University, Kyoto 606-8507, Japan; Department of Computational Biology and Medical Sciences, Graduate School of Frontier Sciences, The University of Tokyo, Chiba 277-856, Japan
| | - Michael Morrison
- Centre for Health, Law and Emerging Technologies (HeLEX), Faculty of Law, University of Oxford, Oxford OX2 7DD, UK; Institute for Science, Innovation and Society, School of Anthropology and Museum Ethnography, University of Oxford, Oxford OX2 6PN, UK.
| | - Jusaku Minari
- Uehiro Research Division of iPS Cell Ethics, Center for iPS Cell Research and Application, Kyoto University, Kyoto 606-8507, Japan.
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36
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Master Z, Matthews KRW, Abou-El-Enein M. Unproven stem cell interventions: A global public health problem requiring global deliberation. Stem Cell Reports 2021; 16:1435-1445. [PMID: 34107243 PMCID: PMC8190665 DOI: 10.1016/j.stemcr.2021.05.004] [Citation(s) in RCA: 26] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/19/2020] [Revised: 05/10/2021] [Accepted: 05/11/2021] [Indexed: 12/12/2022] Open
Abstract
The unproven stem cell intervention (SCI) industry is a global health problem. Despite efforts of some nations, the industry continues to flourish. In this paper, we call for a global approach and the establishment of a World Health Organization (WHO) Expert Advisory Committee on Regenerative Medicine to tackle this issue and provide guidance. The WHO committee can harmonize national regulations; promote regulatory approaches responsive to unmet patient needs; and formulate an education campaign against misinformation. Fostering an international dialog and developing recommendations that can be adopted by member states would effectively address the global market of unproven SCIs.
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Affiliation(s)
- Zubin Master
- Biomedical Ethics Research Program and the Center for Regenerative Medicine, Mayo Clinic, Rochester, MN, USA.
| | - Kirstin R W Matthews
- Baker Institute for Public Policy Center for Health and Biosciences, Rice University, Houston, TX, USA
| | - Mohamed Abou-El-Enein
- Division of Medical Oncology, Department of Medicine, and Department of Stem Cell Biology and Regenerative Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Joint USC/CHLA Cell Therapy Program, University of Southern California, and Children Hospital Los Angeles, Los Angeles, CA, USA.
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37
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Turner L. ISSCR's Guidelines for Stem Cell Research and Clinical Translation: Supporting development of safe and efficacious stem cell-based interventions. Stem Cell Reports 2021; 16:1394-1397. [PMID: 34048693 PMCID: PMC8190662 DOI: 10.1016/j.stemcr.2021.05.011] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/13/2021] [Revised: 05/16/2021] [Accepted: 05/16/2021] [Indexed: 12/02/2022] Open
Abstract
The ISSCR’s revised Guidelines for Stem Cell Research and Clinical Translation reflect the organization’s commitment to opposing premature commercialization of stem cell-based interventions and supporting the development of products that meet stringent ethical, scientific, and regulatory standards. The Guidelines contain five important new recommendations concerning clinical translation of stem cell products.
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Affiliation(s)
- Leigh Turner
- University of Minnesota Center for Bioethics, School of Public Health, and College of Pharmacy, Minneapolis, MN 55455, USA.
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38
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Stem Cell Therapy, Ophthalmic Applications, and the Current Controversies With Direct-to-Consumer Marketing. Int Ophthalmol Clin 2021; 60:179-192. [PMID: 33093325 DOI: 10.1097/iio.0000000000000329] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
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39
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Liu H. Big data precision marketing and consumer behavior analysis based on fuzzy clustering and PCA model. JOURNAL OF INTELLIGENT & FUZZY SYSTEMS 2021. [DOI: 10.3233/jifs-189491] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
Precision marketing is faced with multiple levels of problems, such as pollution of the data environment and unscientific algorithms, which need to be sorted out urgently. Based on neural network technology, this paper constructs a neural network-based precision marketing model and focuses on data mining to study user churn prediction and user value enhancement, which are the two most important factors affecting marketing revenue. Moreover, this paper conducts an empirical test of the product strategy and market strategy adopted by big data precision marketing. According to the characteristics of the user population and the application scenarios of the product, this paper puts the corresponding precision marketing methods in a targeted manner and analyzes the performance of the model through experimental research. The research results show that precision marketing methods based on big data information platforms need to be more detailed and more comprehensive. At the same time, precision marketing methods need to correspond to the sensitive information characteristics of target users and consider the background and current situation of actual market execution to effectively play it role.
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Affiliation(s)
- Hongping Liu
- Qinhuangdao Branch, Northeast Petroleum University, Qinhuangdao, Hebei, China
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40
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Yan T, Pengfei L. Marketing customer response scoring model based on machine learning data analysis. JOURNAL OF INTELLIGENT & FUZZY SYSTEMS 2021. [DOI: 10.3233/jifs-189484] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
In marketing, problems such as the increase in customer data, the increase in the difficulty of data extraction and access, the lack of reliability and accuracy of data analysis, the slow efficiency of data processing, and the inability to effectively transform massive amounts of data into valuable information have become increasingly prominent. In order to study the effect of customer response, based on machine learning algorithms, this paper constructs a marketing customer response scoring model based on machine learning data analysis. In the context of supplier customer relationship management, this article analyzes the supplier’s precision marketing status and existing problems and uses its own development and management characteristics to improve marketing strategies. Moreover, this article uses a combination of database and statistical modeling and analysis to try to establish a customer response scoring model suitable for supplier precision marketing. In addition, this article conducts research and analysis with examples. From the research results, it can be seen that the performance of the model constructed in this article is good.
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Affiliation(s)
- Tang Yan
- School of Business, Liaocheng University, Liaocheng, Shandong, China
| | - Li Pengfei
- School of Foreign Languages, Liaocheng University, Liaocheng, Shandong, China
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41
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Chavez J, Shah NA, Ruoss S, Cuomo RE, Ward SR, Mackey TK. Online marketing practices of regenerative medicine clinics in US-Mexico border region: a web surveillance study. Stem Cell Res Ther 2021; 12:189. [PMID: 33736697 PMCID: PMC7977255 DOI: 10.1186/s13287-021-02254-4] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2020] [Accepted: 03/01/2021] [Indexed: 11/13/2022] Open
Abstract
Introduction The potential of regenerative medicine to improve human health has led to the rapid expansion of stem cell clinics throughout the world with varying levels of regulation and oversight. This has led to a market ripe for stem cell tourism, with Tijuana, Mexico, as a major destination. In this study, we characterize the online marketing, intervention details, pricing of services, and assess potential safety risks through web surveillance of regenerative medicine clinics marketing services in Tijuana. Methods We conducted structured online search queries from March to April 2019 using 296 search terms in English and Spanish on two search engines (Google and Bing) to identify websites engaged in direct-to-consumer advertising of regenerative medicine services. We performed content analysis to characterize three categories of interest: online presence, tokens of scientific legitimacy, and intervention details. Results Our structured online searches resulted in 110 unique websites located in Tijuana corresponding to 76 confirmed locations. These clinics’ online presence consisted of direct-to-consumer advertising mainly through a dedicated website (94.5%) or Facebook page (65.5%). The vast majority of these websites (99.1%) did not mention any affiliation to an academic institutions or other overt tokens of scientific legitimacy. Most clinics claimed autologous tissue was the source of treatments (67.3%) and generally did not specify route of administration. Additionally, of the Tijuana clinics identified, 13 claimed licensing, though only 1 matched with available licensing information. Conclusions Regenerative medicine clinics in Tijuana have a significant online presence using direct-to-consumer advertising to attract stem-cell tourism clientele in a bustling border region between Mexico and the USA. This study adds to existing literature evidencing the unregulated nature of online stem cell offerings and provides further evidence of the need for regulatory harmonization, particularly to address stem cell services being offered online across borders. Supplementary Information The online version contains supplementary material available at 10.1186/s13287-021-02254-4.
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Affiliation(s)
- Javier Chavez
- Masters Program in Clinical Research, UC San Diego - School of Medicine, San Diego, CA, USA
| | - Neal A Shah
- Department of Healthcare Research and Policy, UC San Diego - Extension, 8950 Villa La Jolla Drive Suite A124, San Diego, CA, 92037, USA.,Global Health Policy and Data Institute, San Diego, CA, USA
| | - Severin Ruoss
- Department of Orthopaedic Surgery, UC San Diego - School of Medicine, San Diego, CA, USA
| | - Raphael E Cuomo
- Global Health Policy and Data Institute, San Diego, CA, USA.,Department of Anesthesiology and Division of Global Public Health, University of California, San Diego School of Medicine, San Diego, CA, USA
| | - Samuel R Ward
- Department of Orthopaedic Surgery and Department of Radiology, UC San Diego - School of Medicine, San Diego, CA, USA
| | - Tim K Mackey
- Department of Healthcare Research and Policy, UC San Diego - Extension, 8950 Villa La Jolla Drive Suite A124, San Diego, CA, 92037, USA. .,Global Health Policy and Data Institute, San Diego, CA, USA. .,Department of Anesthesiology and Division of Global Public Health, University of California, San Diego School of Medicine, San Diego, CA, USA. .,S-3 Research, LLC, San Diego, CA, USA.
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42
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Cuende N, Álvarez-Márquez AJ, Díaz-Aunión C, Castro P, Huet J, Pérez-Villares JM. Promoting the ethical use of safe and effective cell-based products: the Andalusian plan on regenerative medicine. Cytotherapy 2020; 22:712-717. [PMID: 32878735 PMCID: PMC7456586 DOI: 10.1016/j.jcyt.2020.07.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2020] [Revised: 07/04/2020] [Accepted: 07/15/2020] [Indexed: 10/25/2022]
Abstract
With regard to regenerative medicine, the expectations generated over the last two decades and the time involved in developing this type of therapies, together with the availability of devices that allow point-of-care treatments through the rapid isolation of cellular or plasma products from patients in the operating theater, represent the perfect breeding ground for the offering of unproven or unregulated therapies on a global scale. A multidisciplinary approach-one based on the collaboration of institutions that, from the perspective of their area of competence, can contribute to reversing this worrying situation-to this problem is essential. It is a priority for local health authorities to take measures that are adapted to the particular situation and regulatory framework of their respective territory. In this article, the authors present the regenerative medicine action plan promoted by the Andalusian Transplant Coordination (i.e., the action plan for the largest region in Spain), highlighting the aspects the authors believe are fundamental to its success. The authors describe, in summary form, the methodology, phases of the plan, actions designed, key collaborators, important milestones achieved and main lessons they have drawn from their experience so that this can serve as an example for other institutions interested in promoting the ethical use of this type of therapy.
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Affiliation(s)
- Natividad Cuende
- Coordinación Autonómica de Trasplantes de Andalucía, Servicio Andaluz de Salud, Sevilla, Spain.
| | | | - Concepción Díaz-Aunión
- Coordinación Autonómica de Trasplantes de Andalucía, Servicio Andaluz de Salud, Sevilla, Spain
| | - Pablo Castro
- Coordinación Autonómica de Trasplantes de Andalucía, Servicio Andaluz de Salud, Sevilla, Spain
| | - Jesús Huet
- Coordinación Autonómica de Trasplantes de Andalucía, Servicio Andaluz de Salud, Sevilla, Spain
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43
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Translating Basic Research into Safe and Effective Cell-based Treatments for Respiratory Diseases. Ann Am Thorac Soc 2020; 16:657-668. [PMID: 30917290 DOI: 10.1513/annalsats.201812-890cme] [Citation(s) in RCA: 20] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
Respiratory diseases, such as chronic obstructive pulmonary disease and pulmonary fibrosis, result in severely impaired quality of life and impose significant burdens on healthcare systems worldwide. Current disease management involves pharmacologic interventions, oxygen administration, reduction of infections, and lung transplantation in advanced disease stages. An increasing understanding of mechanisms of respiratory epithelial and pulmonary vascular endothelial maintenance and repair and the underlying stem/progenitor cell populations, including but not limited to airway basal cells and type II alveolar epithelial cells, has opened the possibility of cell replacement-based regenerative approaches for treatment of lung diseases. Further potential for personalized therapies, including in vitro drug screening, has been underscored by the recent derivation of various lung epithelial, endothelial, and immune cell types from human induced pluripotent stem cells. In parallel, immunomodulatory treatments using allogeneic or autologous mesenchymal stromal cells have shown a good safety profile in clinical investigations for acute inflammatory conditions, such as acute respiratory distress syndrome and septic shock. However, as yet, no cell-based therapy has been shown to be both safe and effective for any lung disease. Despite the investigational status of cell-based interventions for lung diseases, businesses that market unproven, unlicensed and potentially harmful cell-based interventions for respiratory diseases have proliferated in the United States and worldwide. The current status of various cell-based regenerative approaches for lung disease as well as the effect of the regulatory environment on clinical translation of such approaches are presented and critically discussed in this review.
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Qiu T, Hanna E, Dabbous M, Borislav B, Toumi M. Regenerative medicine regulatory policies: A systematic review and international comparison. Health Policy 2020; 124:701-713. [PMID: 32499078 DOI: 10.1016/j.healthpol.2020.05.004] [Citation(s) in RCA: 20] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/29/2019] [Revised: 04/24/2020] [Accepted: 05/03/2020] [Indexed: 02/08/2023]
Abstract
BACKGROUND A small number of regenerative medicines (RMs) have received market authorization (MA) worldwide, relative to the large number of clinical trials currently being conducted. Regulatory issues constitute one major challenge for the MA of RMs. OBJECTIVE This study aimed to systematically review the regulation of RMs internationally, to identify the regulatory pathways for approved RMs, and to detail expedited programs to stimulate MA process. METHODS Official websites of regulatory authorities in 9 countries (United States (US), Japan, South Korea, Australia, Canada, New Zealand, Singapore, China, and India) and the European Union (EU) were systematically browsed, and was complemented by a systematic literature review in Medline and Embase database. RESULTS Specific RM legislation/frameworks were available in the EU, US, Japan, South Korea and Australia. A risk-based approach exempting eligible RMs from MA regulations were adopted in the EU and 6 countries. All investigated regions have established accelerated review or approval programs to facilitate the MA of RMs. 55 RMs have received MA in 9 countries and the EU. Twenty-three RMs received Priority Medicine designation, 32 RMs received Regenerative Medicine Advanced Therapy designation, and 11 RMs received SAKIGAKE (fore-runner initiative) designation. CONCLUSION Regulators have adopted proactive strategies to facilitate RM approval. However, addressing the discrepancies in regulatory requirements internationally remains challenging.
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Affiliation(s)
- Tingting Qiu
- Aix-Marseille University, Public Health Department, 27 Boulevard Jean Moulin, 13385, Marseille, France
| | - Eve Hanna
- Creativ-Ceutical, 215, Rue du Faubourg St-Honoré, 75008, Paris, France
| | - Monique Dabbous
- Aix-Marseille University, Public Health Department, 27 Boulevard Jean Moulin, 13385, Marseille, France
| | | | - Mondher Toumi
- Aix-Marseille University, Public Health Department, 27 Boulevard Jean Moulin, 13385, Marseille, France.
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Ramos O, Speirs JN, Danisa O. Lumbar Discitis and Osteomyelitis After a Spinal Stem Cell Injection?: A Case Report and Literature Review. JBJS Case Connect 2020; 10:e1900636. [PMID: 32773702 DOI: 10.2106/jbjs.cc.19.00636] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/11/2023]
Abstract
CASE A 32-year-old man developed lumbar discitis and osteomyelitis after receiving a cell-based injection for the treatment of degenerative disc disease. Initial cultures were negative, but he continued to worsen, and a repeat set of cultures was taken. On day 10, Cutibacterium acnes was isolated. He was then successfully treated with 12 weeks of intravenous antibiotics. CONCLUSIONS There is minimal regulation on the preparation or administration of cell-based interventions. It is important to consider slow growing organisms such as C. acnes in patients presenting with spinal infection with insidious onset after these treatments.
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Affiliation(s)
- Omar Ramos
- 1Department of Orthopaedic Surgery, Loma Linda University, Loma Linda, California
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Davies JA, Murray P, Wilm B. Regenerative medicine therapies: lessons from the kidney. CURRENT OPINION IN PHYSIOLOGY 2020; 14:41-47. [PMID: 32467861 PMCID: PMC7236377 DOI: 10.1016/j.cophys.2019.12.008] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
We focus on three strategies for renal regenerative medicine; administering cells to replace damaged tissue, promoting endogenous regeneration, and growing stem cell-derived organs. Mouse kidney regeneration can be promoted by stem cells injected into the circulation which do not become new kidney tissue but seem to secrete regeneration-promoting humoral factors. This argues against direct replacement but encourages developing pharmacological stimulators of endogenous regeneration. Simple ‘kidneys’ have been made from stem cells, but there is a large gap between what has been achieved and a useful transplantable organ. Most current work aims to stimulate endogenous regeneration or to grow new organs but much remains to be done; misplaced hype about short-term prospects of regenerative medicine helps neither researchers nor patients.
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Affiliation(s)
- Jamie A Davies
- Deanery of Biomedical Sciences, University of Edinburgh, EH8 9XB, Edinburgh, UK
| | - Patricia Murray
- Department of Cellular and Molecular Physiology, University of Liverpool, UK.,Centre for Preclinical Imaging, University of Liverpool, UK
| | - Bettina Wilm
- Department of Cellular and Molecular Physiology, University of Liverpool, UK.,Centre for Preclinical Imaging, University of Liverpool, UK
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How to Peddle Hope: An Analysis of YouTube Patient Testimonials of Unproven Stem Cell Treatments. Stem Cell Reports 2020; 12:1186-1189. [PMID: 31189092 PMCID: PMC6565870 DOI: 10.1016/j.stemcr.2019.05.009] [Citation(s) in RCA: 29] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2018] [Revised: 05/09/2019] [Accepted: 05/12/2019] [Indexed: 12/11/2022] Open
Abstract
Providers capitalize on patient testimonials to market unproven stem cell treatments (SCTs). We evaluated 159 YouTube videos and found patients discussed health improvements (91.2%), praised providers (53.5%), and recommended SCTs (28.9%). In over a third of the videos, providers posed questions to patients, thereby directing narratives and making them a powerful marketing tool.
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Woodworth CF, Jenkins G, Barron J, Hache N. Intramedullary cervical spinal mass after stem cell transplantation using an olfactory mucosal cell autograft. CMAJ 2020; 191:E761-E764. [PMID: 31285379 DOI: 10.1503/cmaj.181696] [Citation(s) in RCA: 22] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022] Open
Affiliation(s)
- Claire F Woodworth
- Departments of Radiology (Woodworth, Hache), Neurosurgery (Jenkins) and Pathology (Barron), Faculty of Medicine, Memorial University of Newfoundland, St. John's, Nfld
| | - Gregory Jenkins
- Departments of Radiology (Woodworth, Hache), Neurosurgery (Jenkins) and Pathology (Barron), Faculty of Medicine, Memorial University of Newfoundland, St. John's, Nfld
| | - Jane Barron
- Departments of Radiology (Woodworth, Hache), Neurosurgery (Jenkins) and Pathology (Barron), Faculty of Medicine, Memorial University of Newfoundland, St. John's, Nfld
| | - Nanette Hache
- Departments of Radiology (Woodworth, Hache), Neurosurgery (Jenkins) and Pathology (Barron), Faculty of Medicine, Memorial University of Newfoundland, St. John's, Nfld.
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Cuende N, Álvarez-Márquez AJ, Díaz-Aunión C, Castro P, Huet J, Pérez-Villares JM. [The regenerative medicine and stem cell business: confusion with legal implications]. GACETA SANITARIA 2020; 35:374-378. [PMID: 32165038 DOI: 10.1016/j.gaceta.2019.12.004] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/03/2019] [Revised: 12/05/2019] [Accepted: 12/27/2019] [Indexed: 11/30/2022]
Abstract
The rise of regenerative medicine and the growth of the offer of autologous therapies, obtained from blood, cells or tissues of the patients, have been favoured by the current availability of an increasing number of commercial devices. Most of these devices are easy to use, allowing the elaboration of products and its application within the same procedure. Regardless of the questionable efficacy and safety of many of the treatments offered under the claim of stem cells or regenerative medicine, most of the centres and professionals offering these treatments are unaware of the legal requirements and implications of their use. A common confusion consists in not distinguishing between the authorization required by the equipment itself, considered a medical device, and the authorization for the use of the product obtained, usually considered a medicinal product (whether advanced therapy or not) or a transplant. Moreover, these treatments frequently have an experimental nature. In that case, in addition to requiring the corresponding ethical evaluation and the authorization of various regulatory bodies, their administration must be offered free of charge, obtaining the patient's informed consent and after contracting a specific insurance policy. In this article we present a brief summary of the main requirements for the application of these autologous biological products with the aim of serving as a guide both for the professionals who prescribe them and for those who inspect the centres where the products are administered. Finally, we include some recommendations for patients.
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Affiliation(s)
- Natividad Cuende
- Coordinación Autonómica de Trasplantes de Andalucía, Servicio Andaluz de Salud, Sevilla.
| | | | | | - Pablo Castro
- Coordinación Autonómica de Trasplantes de Andalucía, Servicio Andaluz de Salud, Sevilla
| | - Jesús Huet
- Coordinación Autonómica de Trasplantes de Andalucía, Servicio Andaluz de Salud, Sevilla
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Khine KT, Albini TA, Lee RK. Chronic retinal detachment and neovascular glaucoma after intravitreal stem cell injection for Usher Syndrome. Am J Ophthalmol Case Rep 2020; 18:100647. [PMID: 32211560 PMCID: PMC7082495 DOI: 10.1016/j.ajoc.2020.100647] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/19/2018] [Revised: 03/30/2019] [Accepted: 03/02/2020] [Indexed: 10/28/2022] Open
Abstract
A 42-year-old Hispanic female underwent intravitreal autologous adipose-tissue derived stem cell injection to her left eye in the Dominican Republic for treatment of retinitis pigmentosa associated with Usher Syndrome. Prior to intravitreal injection, the patient's best-corrected-visual-acuity (BCVA) was 1/200. The patient experienced decreased vision gradually over a 3-month period. The patient presented with no light perception (NLP) vision with a total funnel retinal detachment, as well as hyphema, iris neovascularization, and nearly 360 posterior synechiae of the iris to the lens capsule. The patient suffered from ocular pain with an intraocular pressure (IOP) of 37 mm Hg. Transcleral cyclophotocoagulation was performed. The IOP was 6 mm Hg six weeks after treatment and the patient was pain free.
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Affiliation(s)
- Kay T Khine
- Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA
| | - Thomas A Albini
- Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA
| | - Richard K Lee
- Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA
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