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World J Stem Cells. May 26, 2026; 18(5): 117591
Published online May 26, 2026. doi: 10.4252/wjsc.v18.i5.117591
Published online May 26, 2026. doi: 10.4252/wjsc.v18.i5.117591
From laboratory to clinic: Bridging regulatory and manufacturing gaps in stem cell-based therapies
Noura A A Ebrahim, Department of Oncologic Pathology, National Cancer Institute, Cairo University, Cairo 11796, Al Qāhirah, Egypt
Thoraya A Farghaly, Ghada S Masaret, Department of Chemistry, Umm Al-Qura University, Makkah 21955, Saudi Arabia
Amani M R Alsaedi, Department of Chemistry, Collage of Science, Taif University, Taif 21944, Saudi Arabia
Soliman M A Soliman, Department of Chemistry, Faculty of Science, Cairo University, Cairo 12613, Al Qāhirah, Egypt
Co-corresponding authors: Noura A A Ebrahim and Soliman M A Soliman.
Author contributions: Ebrahim NAA and Soliman SMA contributed equally to the conceptualization and drafting of the manuscript, they contributed equally to this manuscript and are co-corresponding authors. Ebrahim NAA, Farghaly TA, Masaret GS, Alsaedi AMR, and Soliman SMA contributed in drafting and critical revision of the manuscript.
AI contribution statement: The manuscript text was written by the authors. Paperpal was used for language polishing only. No AI tool participate in design of the study or interpretation of its results. No images in the manuscript generated by AI.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Corresponding author: Noura A A Ebrahim, Department of Oncologic Pathology, National Cancer Institute, Cairo University, 1st Kasr Al Ainy Street, Cairo 11796, Al Qāhirah, Egypt.
Received: December 11, 2025
Revised: February 5, 2026
Accepted: March 10, 2026
Published online: May 26, 2026
Processing time: 165 Days and 21.8 Hours
Revised: February 5, 2026
Accepted: March 10, 2026
Published online: May 26, 2026
Processing time: 165 Days and 21.8 Hours
Core Tip
Core Tip: This review outlines the major scientific, regulatory, and manufacturing challenges that limit the clinical translation of stem cell-based advanced therapies. It highlights practical strategies - ranging from tumorigenicity assessment for induced pluripotent stem cells and good manufacturing practice-ready production of mesenchymal stem cell-derived exosomes to artificial intelligence-driven process monitoring and digital-twin modeling - that can support safer, scalable, and more consistent development of stem cell and extracellular-vesicle therapeutics.