Publication Name	World Journal of Stem Cells
Manuscript ID	117591
Country	Egypt

Category	Biology
Manuscript Type	Minireviews
Article Title	From laboratory to clinic: Bridging regulatory and manufacturing gaps in stem cell-based therapies
Manuscript Source	Invited Manuscript
All Author List	Noura A A Ebrahim, Thoraya A Farghaly, Ghada S Masaret, Amani M R Alsaedi and Soliman M A Soliman
Funding Agency and Grant Number
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. npathologist@gmail.com
Key Words	Advanced therapy medicinal products; Stem cell manufacturing platforms; Global regulatory alignment; Safety and tumorigenicity of induced pluripotent stem cells-derived products; Exosome-based mesenchymal stem cell therapies
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.
Citation	Ebrahim NAA, Farghaly TA, Masaret GS, Alsaedi AMR, Soliman SMA. From laboratory to clinic: Bridging regulatory and manufacturing gaps in stem cell-based therapies. World J Stem Cells 2026; In press

Received	2025-12-11 01:13
Peer-Review Started	2025-12-11 01:13
First Decision by Editorial Office Director	2026-01-22 07:58
Return for Revision	2026-01-22 07:58
Revised	2026-02-05 00:33
Publication Fee Transferred
Second Decision by Editor	2026-03-05 02:56
Second Decision by Editor-in-Chief
Final Decision by Editorial Office Director	2026-03-10 06:58
Articles in Press	2026-03-10 06:58
Edit the Manuscript by Language Editor
Typeset the Manuscript

ISSN	1948-0210 (online)
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Copyright	©Author(s) (or their employer(s)) 2026. No commercial re-use. See Permissions. Published by Baishideng Publishing Group Inc.
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