From laboratory to clinic: Bridging regulatory and manufacturing gaps in stem cell-based therapies

doi:10.4252/wjsc.v18.i5.117591

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World Journal of Stem Cells

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1948-0210

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

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Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.

World J Stem Cells. May 26, 2026; 18(5): 117591
Published online May 26, 2026. doi: 10.4252/wjsc.v18.i5.117591

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Figure 1 Global regulatory landscape for cell- and gene-based therapeutics. A unified comparison of the regulatory systems guiding advanced therapy medicinal product oversight across major regions illustrating regional differences influencing product development and market authorization. EU: European Union; ATMP: Advanced therapy medicinal product; GMP: Good manufacturing practice; FDA: Food and Drug Administration; RMAT: Regenerative medicine advanced therapy; PMDA: Pharmaceuticals and Medical Devices Agency.

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

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 [DOI: 10.4252/wjsc.v18.i5.117591]

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