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Within this evolving field, mesenchymal stem cell-derived extracellular vesicles (MSC-EVs) have emerged as a leading platform. These nanoscale vesicles deliver bioactive cargo that mediates critical therapeutic functions, including immunomodulation, angiogenesis, and anti-fibrosis. Furthermore, they offer improved safety, greater potential for standardization, and enhanced scalability compared to traditional live-cell therapies. However, clinical translation remains constrained by several challenges, such as inherent vesicle heterogeneity, limited targeting specificity, and bottlenecks in large-scale manufacturing. This review systematically examines the biogenesis of MSC-EVs, focusing specifically on exosomes, microvesicles, and apoptotic vesicles. We evaluate their functional performance across diverse regeneration contexts, encompassing orofacial, barrier, musculoskeletal, and visceral tissue regeneration. We further highlight innovative engineering strategies designed to enhance therapeutic efficacy, such as surface modification, cargo loading, and biomaterial-integrated delivery systems. In addition, we introduce an emerging approach utilizing engineered MSC aggregate-derived EVs inspired by organ morphogenesis. Finally, this article details the strategic framework required for clinical translation. The framework encompasses scalable production, rigorous quality control, comprehensive non-clinical studies, evolving regulatory pathways, and the current clinical trial landscape. Collectively, this work provides an integrated roadmap for advancing MSC-EVs as a next-generation precision platform for cell-free therapeutics.<\/jats:p>","DOI":"10.1093\/burnst\/tkag030","type":"journal-article","created":{"date-parts":[[2026,4,14]],"date-time":"2026-04-14T11:27:24Z","timestamp":1776166044000},"source":"Crossref","is-referenced-by-count":1,"title":["Tissue regeneration strategies based on mesenchymal stem cell-derived extracellular vesicles: from bench to bedside"],"prefix":"10.1093","volume":"14","author":[{"given":"Shi-Han","family":"Mu","sequence":"first","affiliation":[{"name":"State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi International Joint Research Center for Oral Diseases, Center for Tissue Engineering, School of Stomatology, Fourth Military Medical University , 145 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]},{"name":"State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Clinical Research Center for Oral Diseases, Department of Orthodontics, School of Stomatology, Fourth Military Medical University , 145 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rang","family":"Li","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi International Joint Research Center for Oral Diseases, Center for Tissue Engineering, School of Stomatology, Fourth Military Medical University , 145 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]},{"name":"State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Key Laboratory of Stomatology, Department of Operative Dentistry and Endodontics, School of Stomatology, Fourth Military Medical University , 145 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peng-Fei","family":"Wang","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi International Joint Research Center for Oral Diseases, Center for Tissue Engineering, School of Stomatology, Fourth Military Medical University , 145 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]},{"name":"State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Clinical Research Center for Oral Diseases, Department of Orthodontics, School of Stomatology, Fourth Military Medical University , 145 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]},{"name":"School of Basic Medicine, Fourth Military Medical University , 169 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying-Shuang","family":"Shi","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi International Joint Research Center for Oral Diseases, Center for Tissue Engineering, School of Stomatology, Fourth Military Medical University , 145 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]},{"name":"State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Clinical Research Center for Oral Diseases, Department of Orthodontics, School of Stomatology, Fourth Military Medical University , 145 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]},{"name":"School of Basic Medicine, Fourth Military Medical University , 169 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu-Wei","family":"Zhou","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi International Joint Research Center for Oral Diseases, Center for Tissue Engineering, School of Stomatology, Fourth Military Medical University , 145 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]},{"name":"State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Clinical Research Center for Oral Diseases, Department of Orthodontics, School of Stomatology, Fourth Military Medical University , 145 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]},{"name":"School of Basic Medicine, Fourth Military Medical University , 169 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2586-1152","authenticated-orcid":false,"given":"Yan","family":"Jin","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi International Joint Research Center for Oral Diseases, Center for Tissue Engineering, School of Stomatology, Fourth Military Medical University , 145 West Changle Road, Xincheng District, Xi\u2019an, Shaanxi 710032 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