Efficacy and safety of exosomes from Wharton’s Jelly-derived mesenchymal stem cells in traumatic brain injury

doi:10.5492/wjccm.v14.i4.103782

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World Journal of Critical Care Medicine

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2220-3141

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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World J Crit Care Med. Dec 9, 2025; 14(4): 103782
Published online Dec 9, 2025. doi: 10.5492/wjccm.v14.i4.103782

Efficacy and safety of exosomes from Wharton’s Jelly-derived mesenchymal stem cells in traumatic brain injury

Serdar Kabatas, Erdinç Civelek, Eyüp Can Savrunlu, Necati Kaplan, Tunç Akkoc, Nurten Küçükçakır, Mehmet Bozkurt, Erdal Karaöz

Serdar Kabatas, Erdinç Civelek, Eyüp Can Savrunlu, Department of Neurosurgery, University of Health Sciences Turkey, Gaziosmanpaşa Training and Research Hospital, Istanbul 34255, Türkiye

Serdar Kabatas, Center for Stem Cell and Gene Therapy Research and Practice, University of Health Sciences Turkey, Istanbul 34255, Türkiye

Necati Kaplan, Department of Neurosurgery, Istanbul Rumeli University, Optimed International Çorlu Hospital, Tekirdağ 59860, Türkiye

Tunç Akkoc, Department of Pediatric Allergy-Immunology, Marmara University, Istanbul 34899, Türkiye

Tunç Akkoc, Department of Immunology, Marmara University, Istanbul 34854, Türkiye

Nurten Küçükçakır, Department of Physical Medicine and Rehabilitation, Romatem Bursa Hospital, Bursa 16080, Türkiye

Mehmet Bozkurt, Plastic Reconstructive and Aesthetic Surgery, Private Practice, Istanbul 34367, Türkiye

Erdal Karaöz, Center for Regenerative Medicine and Stem Cell Research and Manufacturing (LivMedCell), Liv Hospital, Istanbul 34340, Türkiye

Erdal Karaöz, Histology and Embryology, Faculty of Medicine, Istinye University, Istanbul 34010, Türkiye

Erdal Karaöz, Center for Stem Cell and Tissue Engineering Research and Practice, Istinye University, Istanbul 34340, Türkiye

Author contributions: Kabatas S, Civelek E and Savrunlu EC designed the research study; Civelek E, Kabatas S, Savrunlu EC, Kaplan N, Küçükçakır N, Bozkurt M performed the research; Kabatas S, Civelek E, Savrunlu EC, Akkoc T Kaplan N contributed new reagents and analytic tools; Civelek E, Kabatas S, Kaplan N, Savrunlu EC, Akkoç T, Bozkurt M, Küçükçakır N, Karaöz E analyzed the data and wrote the manuscript; All authors have read and approved the final manuscript.

Institutional review board statement: The present study was approved by the local medical ethics committee (protocol number: 22122023.1).

Informed consent statement: There is human subject in this article and written informed consents were obtained from the patient for their anonymized information to be published in this article and before the stem cell therapies.

Conflict-of-interest statement: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.

Data sharing statement: No additional data are available.

Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/

Corresponding author: Serdar Kabatas, MD, Full Professor, Department of Neurosurgery, University of Health Sciences Turkey, Gaziosmanpaşa Training and Research Hospital, Karayolları Mahallesi, Osmanbey Caddesi 616. Sokak No. 10, Gaziosmanpaşa, Istanbul 34255, Türkiye. kabatasserdar@hotmail.com

Received: December 4, 2024
Revised: April 1, 2025
Accepted: June 7, 2025
Published online: December 9, 2025
Processing time: 364 Days and 0.2 Hours

Abstract

BACKGROUND

Traumatic brain injury (TBI) is a significant public health issue, leading to long-term neurological impairments. Current treatments offer limited recovery, particularly in restoring lost functions. Mesenchymal stem cell-derived exosomes (MSCdE) have shown potential for promoting neuroprotection and regeneration. This study evaluates the safety and efficacy of MSCdE therapy in TBI patients.

AIM

To evaluate the safety and efficacy of MSCdE therapy in TBI patients.

METHODS

Five patients (mean age 27.00 ± 4.06 years) with TBI from combat injuries were treated with six rounds of MSCdE therapy (3 mL intrathecally and 3 mL intramuscularly per round). The patients were followed for one year. Adverse events were assessed using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0), and functional outcomes were evaluated with the functional independence measure (FIM), Modified Ashworth Scale (MAS), and Karnofsky Performance Scale (KPS).

RESULTS

No serious adverse events occurred, and only mild side effects [subfebrile fever (37.5 °C-37.9 °C), pain] were reported (CTCAE Grade 1). FIM motor scores improved significantly (46.20 ± 16.39 to 64.20 ± 18.20, P < 0.01), and FIM cognitive scores also showed significant improvement (30.60 ± 4.56 to 34.00 ± 1.41, P < 0.001). While MAS scores improved (right/left: 4.60/3.60 to 2.20/1.60), these changes were not statistically significant (P > 0.05), possibly due to low baseline spasticity. KPS scores significantly improved (46.00 ± 11.40 to 72.00 ± 8.37, P < 0.001), indicating enhanced overall functional status and quality of life.

CONCLUSION

MSCdE therapy is safe and effective in improving motor function, cognition, and quality of life in TBI patients. Larger, controlled trials are needed to further validate these findings and optimize MSCdE therapy for TBI treatment.

Keywords: Exosome therapy; Mesenchymal stem cells; Neuroprotection; Traumatic brain injury; Neuroregeneration

Core Tip: Mesenchymal stem cell-derived exosomes (MSCdE) therapy shows promise for traumatic brain injury (TBI) patients, with significant improvements in motor and cognitive function reflected in functional independence measure scores. The treatment was well tolerated, with mild, temporary side effects such as subfebrile fever and pain, and no serious adverse events reported. Enhanced Karnofsky Performance Scale scores suggest improved quality of life and functional status, supporting its potential for long-term recovery. While spasticity improvement was observed, it was not statistically significant, possibly due to mild baseline spasticity. These findings support MSCdE therapy as a potential treatment for TBI, warranting further validation through larger randomized controlled trials.