弥合差距：脂肪来源干细胞的临床转化——一项临床试验的范围综述

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

作者信息

Su Hankun, Chau Hoksan, Li Qilin, Xiao Fen, Sun Yuanyuan, Chen Jingjing, He Yayi, Ning Jinyao, Hu Qin, Xiao Yujie, Li Caiwen, Huang Bixia, Zhao Jing, Li Yanping, Li Hui

机构信息

Department of Reproductive Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China.

Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, Hunan Province, China.

出版信息

Stem Cell Res Ther. 2025 Jun 7;16(1):288. doi: 10.1186/s13287-025-04405-3.

DOI:10.1186/s13287-025-04405-3

PMID:40483503

Abstract

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 .

摘要

背景

脂肪来源干细胞（ADSCs）因其多能性、免疫调节特性及易于获取，已成为再生医学中一种有前景的治疗工具。尽管进行了广泛的临床前研究，但ADSCs的临床转化仍然零散，在标准化、可重复性和证据整合方面存在挑战。

目的

本综述在文献计量分析的辅助下，旨在描绘评估ADSC疗法的随机对照试验（RCTs）的全景，确定基础研究与临床转化之间的差距，并突出该领域的新趋势。

方法

对Web of Science、PubMed、Embase、ClinicalTrials.gov、EudraCT和中国临床试验注册中心数据库（2009 - 2025年）进行系统检索，确定了82项RCTs。使用VoSviewer对临床前研究进行文献计量分析，以可视化关键词聚类和时间趋势。提取并综合了关于试验特征、终点和转化挑战的数据。

结果

纳入的82项RCTs涵盖17个医学专科，其中骨科（26.8%）、皮肤科（14.6%）和神经科（9.7%）研究最多。西班牙（21.95%）、中国（18.29%）和美国（15.85%）的试验数量领先，但97%为单国研究，样本量中位数为40。主要终点从安全性向有效性转变。文献计量分析揭示了三个聚类：干细胞来源与基础生物学、骨科应用和组织再生机制。关键差距包括方案异质性（如分离方法、冷冻保存变异性）、监管碎片化、长期随访有限以及临床结果不一致，特别是在神经科。新趋势突出了基质血管成分（SVF）和ADSC来源外泌体的治疗潜力。