{"title":"弥合差距：脂肪来源干细胞的临床翻译-临床试验的范围审查。","authors":"Hankun Su, Hoksan Chau, Qilin Li, Fen Xiao, Yuanyuan Sun, Jingjing Chen, Yayi He, Jinyao Ning, Qin Hu, Yujie Xiao, Caiwen Li, Bixia Huang, Jing Zhao, Yanping Li, Hui Li","doi":"10.1186/s13287-025-04405-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Adipose-derived stem cells (ADSCs) have emerged as a promising therapeutic tool in regenerative medicine due to their multipotency, immunomodulatory properties, and ease of procurement. Despite extensive preclinical research, the clinical translation of ADSCs remains fragmented, with challenges in standardization, reproducibility, and evidence synthesis.</p><p><strong>Objective: </strong>This scoping review, complemented by bibliometric analysis, aims to map the landscape of randomized controlled trials (RCTs) evaluating ADSC therapies, identify gaps between basic research and clinical translation, and highlight emerging trends in the field.</p><p><strong>Methods: </strong>A systematic search of Web of Science, PubMed, Embase, ClinicalTrials.gov, EudraCT, and ChiCTR database (2009-2025) identified 82 RCTs. Bibliometric analysis of preclinical studies was conducted using VoSviewer to visualize keyword clusters and temporal trends. Data on trial characteristics, endpoints, and translational challenges were extracted and synthesized.</p><p><strong>Results: </strong>The 82 included RCTs spanned 17 medical specialties, with orthopedics (26.8%), dermatology (14.6%), and neurology (9.7%) being the most studied. Spain (21.95%) and China (18.29%) and the USA (15.85%) led trial numbers, but 97% were single-country studies with a median sample size of 40. Primary endpoints trends from safety to efficacy. Bibliometric analysis revealed three clusters: stem cell sources and basic biology, orthopedic applications, and tissue regeneration mechanisms. Key gaps included protocol heterogeneity (e.g., isolation methods, cryopreservation variability), regulatory fragmentation, limited long-term follow-up, and inconsistent clinical outcomes, particularly in neurology. Emerging trends highlighted the therapeutic potential of stromal vascular fraction (SVF) and ADSC-derived exosomes.</p><p><strong>Conclusions: </strong>While ADSCs demonstrate significant therapeutic potential, clinical translation is hindered by standardization deficits and mechanistic knowledge gaps. Future research should prioritize international collaboration, large-scale trials, and mechanistic studies to optimize ADSC therapies. Innovations in SVF and exosome-based treatments represent promising avenues for advancing regenerative medicine.</p><p><strong>Trial registry: </strong>This scoping review was preregistered at OSF platform: https://doi.org/10.17605/OSF.IO/YKHW3 .</p>","PeriodicalId":21876,"journal":{"name":"Stem Cell Research & Therapy","volume":"16 1","pages":"288"},"PeriodicalIF":7.1000,"publicationDate":"2025-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12145640/pdf/","citationCount":"0","resultStr":"{\"title\":\"Bridging the gap: clinical translation of adipose-derived stem cells - a scoping review of clinical trials.\",\"authors\":\"Hankun Su, Hoksan Chau, Qilin Li, Fen Xiao, Yuanyuan Sun, Jingjing Chen, Yayi He, Jinyao Ning, Qin Hu, Yujie Xiao, Caiwen Li, Bixia Huang, Jing Zhao, Yanping Li, Hui Li\",\"doi\":\"10.1186/s13287-025-04405-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Adipose-derived stem cells (ADSCs) have emerged as a promising therapeutic tool in regenerative medicine due to their multipotency, immunomodulatory properties, and ease of procurement. 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Data on trial characteristics, endpoints, and translational challenges were extracted and synthesized.</p><p><strong>Results: </strong>The 82 included RCTs spanned 17 medical specialties, with orthopedics (26.8%), dermatology (14.6%), and neurology (9.7%) being the most studied. Spain (21.95%) and China (18.29%) and the USA (15.85%) led trial numbers, but 97% were single-country studies with a median sample size of 40. Primary endpoints trends from safety to efficacy. Bibliometric analysis revealed three clusters: stem cell sources and basic biology, orthopedic applications, and tissue regeneration mechanisms. Key gaps included protocol heterogeneity (e.g., isolation methods, cryopreservation variability), regulatory fragmentation, limited long-term follow-up, and inconsistent clinical outcomes, particularly in neurology. 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引用次数: 0
摘要
背景：脂肪源性干细胞（ADSCs）由于其多能性、免疫调节特性和易于获取，已成为再生医学中很有前途的治疗工具。尽管有广泛的临床前研究，但ADSCs的临床翻译仍然是碎片化的，在标准化、可重复性和证据合成方面面临挑战。目的：本综述以文献计量学分析为补充，旨在绘制评估ADSC治疗的随机对照试验（rct）的图景，确定基础研究与临床转化之间的差距，并强调该领域的新趋势。方法：系统检索Web of Science、PubMed、Embase、ClinicalTrials.gov、euddraft和ChiCTR数据库（2009-2025），确定82项随机对照试验。使用VoSviewer对临床前研究进行文献计量分析，以可视化关键词集群和时间趋势。提取和合成有关试验特征、终点和翻译挑战的数据。结果：纳入的82项随机对照试验涵盖17个医学专科，其中骨科（26.8%）、皮肤科（14.6%）和神经内科（9.7%）的研究最多。西班牙（21.95%）、中国（18.29%）和美国（15.85%）的试验数量最多，但97%是单个国家的研究，中位样本量为40。主要终点从安全性到有效性的趋势。文献计量学分析揭示了三个集群：干细胞来源和基础生物学，骨科应用和组织再生机制。主要的差距包括方案的异质性（例如，分离方法、冷冻保存的可变性）、监管的碎片化、有限的长期随访和不一致的临床结果，特别是在神经病学方面。新兴趋势强调了基质血管分数（SVF）和adsc衍生的外泌体的治疗潜力。结论：虽然ADSCs显示出显著的治疗潜力，但临床转化受到标准化缺陷和机制知识空白的阻碍。未来的研究应优先考虑国际合作、大规模试验和机制研究，以优化ADSC治疗。SVF和基于外泌体的治疗的创新代表了推进再生医学的有希望的途径。试验注册：该范围审查已在OSF平台上预注册：https://doi.org/10.17605/OSF.IO/YKHW3。
Bridging the gap: clinical translation of adipose-derived stem cells - a scoping review of clinical trials.
Background: Adipose-derived stem cells (ADSCs) have emerged as a promising therapeutic tool in regenerative medicine due to their multipotency, immunomodulatory properties, and ease of procurement. Despite extensive preclinical research, the clinical translation of ADSCs remains fragmented, with challenges in standardization, reproducibility, and evidence synthesis.
Objective: This scoping review, complemented by bibliometric analysis, aims to map the landscape of randomized controlled trials (RCTs) evaluating ADSC therapies, identify gaps between basic research and clinical translation, and highlight emerging trends in the field.
Methods: A systematic search of Web of Science, PubMed, Embase, ClinicalTrials.gov, EudraCT, and ChiCTR database (2009-2025) identified 82 RCTs. Bibliometric analysis of preclinical studies was conducted using VoSviewer to visualize keyword clusters and temporal trends. Data on trial characteristics, endpoints, and translational challenges were extracted and synthesized.
Results: The 82 included RCTs spanned 17 medical specialties, with orthopedics (26.8%), dermatology (14.6%), and neurology (9.7%) being the most studied. Spain (21.95%) and China (18.29%) and the USA (15.85%) led trial numbers, but 97% were single-country studies with a median sample size of 40. Primary endpoints trends from safety to efficacy. Bibliometric analysis revealed three clusters: stem cell sources and basic biology, orthopedic applications, and tissue regeneration mechanisms. Key gaps included protocol heterogeneity (e.g., isolation methods, cryopreservation variability), regulatory fragmentation, limited long-term follow-up, and inconsistent clinical outcomes, particularly in neurology. Emerging trends highlighted the therapeutic potential of stromal vascular fraction (SVF) and ADSC-derived exosomes.
Conclusions: While ADSCs demonstrate significant therapeutic potential, clinical translation is hindered by standardization deficits and mechanistic knowledge gaps. Future research should prioritize international collaboration, large-scale trials, and mechanistic studies to optimize ADSC therapies. Innovations in SVF and exosome-based treatments represent promising avenues for advancing regenerative medicine.
Trial registry: This scoping review was preregistered at OSF platform: https://doi.org/10.17605/OSF.IO/YKHW3 .
期刊介绍：
Stem Cell Research & Therapy serves as a leading platform for translational research in stem cell therapies. This international, peer-reviewed journal publishes high-quality open-access research articles, with a focus on basic, translational, and clinical research in stem cell therapeutics and regenerative therapies. Coverage includes animal models and clinical trials. Additionally, the journal offers reviews, viewpoints, commentaries, and reports.
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