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Background <p>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> Objective <p>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> Methods <p>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> Results <p>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> Conclusions <p>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> Trial registry <p>This scoping review was preregistered at OSF platform: <a href="https://doi.org/10.17605/OSF.IO/YKHW3">https://doi.org/10.17605/OSF.IO/YKHW3</a>.</p>

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Bridging the gap: clinical translation of adipose-derived stem cells - a scoping review of clinical trials

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月7日

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  • 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

摘要

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.