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This review assesses key hurdles across in vitro, in vivo, and clinical stages and summarizes emerging solutions to support dependable, safe, and accessible MSC 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of\u003Cbr>Stem Cells |\n| --- | --- | --- | --- | --- |\n\nSubmit a Manuscript: [https://www.f6publishing.com](https://www.f6publishing.com) World J Stem Cells 2025 December 26; 17(12): 114349  \nDOI: 10.4252/wjsc.v17.i12.114349 ISSN 1948-0210 (online)  \nREVIEW  \nHurdles to overcome for mesenchymal stem cell translation from bench to bedside  \nNaiyareen Fareeza Mayeen, Umme Salma, Noor Hayaty Abu Kasim, Okba Mahmoud, Nazmul Haque  \nSpecialty type: Cell and tissue engineering  \nProvenance and peer review:  \nInvited article; Externally peer reviewed.  \nPeer-review model: Single blind  \nPeer-review report’s classification Scientific Quality: Grade B, Grade B  \nNovelty: Grade B, Grade C  \nCreativity or Innovation: Grade B, Grade C  \nScientific Significance: Grade B, Grade B  \nP-Reviewer: Dai XL, Assistant Professor, Chief Physician, China; Ding LJ, PhD, Professor, China  \nReceived: September 17, 2025  \nRevised: October 20, 2025  \nAccepted: November 21, 2025  \nPublished online: December 26, 2025  \nProcessing time: 99 Days and 15.9 Hours  \nNaiyareen Fareeza Mayeen, Department of Biology, University of Rochester, Rochester, NY 14627, United States  \nUmme Salma, Regenerative Medicine, Dhaka 1209, Bangladesh  \nNoor Hayaty Abu Kasim, Department of Restorative Dentistry, University of Malaya, Kuala Lumpur 50603, Malaysia  \nOkba Mahmoud, Department of Clinical Science, Ajman University, Ajman 346, United Arab Emirates  \nNazmul Haque, Department of Regenerative Medicine, Concord Stem Cell Limited, Dhaka 1209, Bangladesh  \nCo-first authors: Naiyareen Fareeza Mayeen and Umme Salma.  \nCorresponding author: Nazmul Haque, PhD, Chief, Head, Department of Regenerative Medicine, Concord Stem Cell Limited, 3, Sima Blossom, Road 16, Dhanmondi, Dhaka 1209, [Bangladesh.](Bangladesh. haquen1983@gmail.com)[ haquen1983@gmail.com](Bangladesh. haquen1983@gmail.com)  \nAbstract  \nMesenchymal stem or stromal cells (MSCs) are among the most extensively studied cell populations in regenerative medicine due to their multipotent differentiation potential, secretion of trophic factors, and immunomodulatory effects. Over the past two decades, preclinical studies have demonstrated encouraging results across musculoskeletal, cardiovascular, neurological, and immunemediated disorders. However, the translation of MSCs from the laboratory to routine clinical practice remains hindered by unresolved scientific, technical, and regulatory challenges. This review provides a critical appraisal of these hurdles, organized across three major stages of translation: In vitro research, in vivo animal studies, and clinical application. In vitro issues include the heterogeneity of isolation techniques, replicative senescence during expansion, genetic and epigenetic instability, and the need for xeno-free, standardized culture platforms. In vivo challenges arise from poor cell survival, low engraftment rates, off-target migration, and microenvironmental influences that shape therapeutic outcomes. Clinical translation introduces additional complexity, including inter-patient variability, large-scale manufacturing difficulties, stringent regulatory compliance, high production costs, and the absence of harmonized potency assays. Solutions under exploration include the use of automated bioreactors, biomimetic scaffolds,  \n WJSC  [https://www.wjgnet.com](https://www.wjgnet.com) 1 December 26, 2025  Volume 17  Issue 12   \nMayeen NF et al. Hurdles in MSC therapy  \nhypoxic preconditioning, extracellular vesicle-based therapies, and international standardization efforts. Addressing these hurdles through multidisciplinary collaboration is essential for MSC-based therapies to become reliable, safe, and accessible regenerative treatments.  \nKey Words: Regenerative medicine; Clinical translation; Stem cell expansion; Scaffolds; Immunomodulation; Good manufacturing practice  \n©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.  \nCore Tip:","cbCaiuPYstfTM8oi","https://ap.wps.com/l/cbCaiuPYstfTM8oi","pdf",895853,"English","# Abstract\n# Core Tip\n# Citation","[{\"question\":\"What are the major stages of MSC translation discussed in the review?\",\"answer\":\"The review organizes hurdles into three major stages: in vitro research, in vivo animal studies, and clinical application.\"},{\"question\":\"Which in vitro challenges are highlighted for MSC translation?\",\"answer\":\"In vitro issues include isolation technique heterogeneity, replicative senescence during expansion, genetic and epigenetic instability, and the need for xeno-free standardized culture platforms.\"},{\"question\":\"What kinds of clinical translation difficulties does the review emphasize?\",\"answer\":\"Clinical translation adds inter-patient variability, large-scale manufacturing challenges, stringent regulatory compliance, high production costs, and the lack of harmonized potency assays.\"}]","Hurdles to overcome for mesenchymal stem cell translation from bench to bedside | PDF",1790567957,48]