本系统综述考察了细胞外囊泡 (EV) 相关临床试验的概况，以阐明该领域在临床应用和 EV 相关方法学方面的趋势，并额外关注对 EV 亚群的认可。通过分析公共报告存储库的数据，我们对迄今为止的 471 项 EV 相关临床试验进行了分类，涵盖 200 多种疾病的适应症。诊断和伴随诊断代表了大部分与 EV 相关的临床试验，其中癌症是最常见的应用。 EV 相关的治疗试验主要利用间充质基质细胞 (MSC) EV，最常用于治疗呼吸系统疾病。超速离心和 RNA 测序是最常见的分离和表征技术；然而，研究记录中并不经常报告每种方法的方法。大多数报告的表征依赖于 EV 分离株的批量表征，只有 11% 在其实验设计中利用了 EV 亚群。虽然这可能与缺乏适合临床实施的可用技术有关，但它也凸显了使用 EV 亚群来改善转化工作的机会。随着学术研究确定了更多化学上不同的亚群和富集技术，我们预计在不久的将来将进行更精细的电动汽车试验。本综述强调需要进行细致的方法学报告并考虑 EV 亚群，以提高基于 EV 的干预措施的转化成功，指出个性化医疗的范式转变。© 2024 作者。 《Journal of Extracellular Vesicles》由 Wiley periodicals LLC 代表国际细胞外囊泡学会出版。

This systematic review examines the landscape of extracellular vesicle (EV)-related clinical trials to elucidate the field's trends in clinical applications and EV-related methodologies, with an additional focus on the acknowledgement of EV subpopulations. By analysing data from public reporting repositories, we catalogued 471 EV-related clinical trials to date, with indications for over 200 diseases. Diagnostics and companion diagnostics represented the bulk of EV-related clinical trials with cancer being the most frequent application. EV-related therapeutics trials mainly utilized mesenchymal stromal cell (MSC) EVs and were most frequently used for treatment of respiratory illnesses. Ultracentrifugation and RNA-sequencing were the most common isolation and characterization techniques; however, methodology for each was not frequently reported in study records. Most of the reported characterization relied on bulk characterization of EV isolates, with only 11% utilizing EV subpopulations in their experimental design. While this may be connected to a lack of available techniques suitable for clinical implementation, it also highlights the opportunity for use of EV subpopulations to improve translational efforts. As academic research identifies more chemically distinct subpopulations and technologies for their enrichment, we forecast to more refined EV trials in the near future. This review emphasizes the need for meticulous methodological reporting and consideration of EV subpopulations to enhance the translational success of EV-based interventions, pointing towards a paradigm shift in personalized medicine.© 2024 The Author(s). Journal of Extracellular Vesicles published by Wiley Periodicals LLC on behalf of International Society for Extracellular Vesicles.