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5/25/2026 9:59:11 AM | Browse: 7 | Download: 0
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Received |
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2025-12-11 01:13 |
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Peer-Review Started |
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2025-12-11 01:13 |
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First Decision by Editorial Office Director |
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2026-01-22 07:58 |
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Return for Revision |
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2026-01-22 07:58 |
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Revised |
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2026-02-05 00:33 |
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Publication Fee Transferred |
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Second Decision by Editor |
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2026-03-05 02:56 |
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Second Decision by Editor-in-Chief |
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Final Decision by Editorial Office Director |
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2026-03-10 06:58 |
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Articles in Press |
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2026-03-10 06:58 |
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Edit the Manuscript by Language Editor |
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Typeset the Manuscript |
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2026-05-13 00:26 |
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Publish the Manuscript Online |
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2026-05-25 07:47 |
| ISSN |
1948-0210 (online) |
| 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: http://creativecommons.org/Licenses/by-nc/4.0/ |
| Copyright |
©Author(s) (or their employer(s)) 2026. No commercial re-use. See Permissions. Published by Baishideng Publishing Group Inc. |
| Article Reprints |
For details, please visit: http://www.wjgnet.com/bpg/gerinfo/247
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| Permissions |
For details, please visit: http://www.wjgnet.com/bpg/gerinfo/207
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| Publisher |
Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA |
| Website |
http://www.wjgnet.com |
| Category |
Biology |
| Manuscript Type |
Minireviews |
| Article Title |
From laboratory to clinic: Bridging regulatory and manufacturing gaps in stem cell-based therapies
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| 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 |
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| 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. |
| Publish Date |
2026-05-25 07:47 |
| 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; 18(5): 117591 |
| URL |
https://www.wjgnet.com/1948-0210/full/v18/i5/117591.htm |
| DOI |
https://dx.doi.org/10.4252/wjsc.v18.i5.117591 |
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