团体标准《人多能干细胞来源的小细胞外囊泡》与《人间充质干细胞来源的小细胞外囊泡》解读

Interpretation of group standards"Requirements for human pluripotent stem cell derived small extracellular vesicles"and"Human mesenchymal stem cell-derived small extracellular vesicles"

人干细胞来源的小细胞外囊泡(sEVs)作为“无细胞的干细胞治疗技术”,在多种疾病的临床前研究中展现出显著的治疗效果,并逐步开展了多项临床试验。然而目前人干细胞来源的sEVs的质量属性尚缺乏统一标准,限制了其进一步临床应用。为此,中国研究型医院学会细胞外囊泡研究与应用专业委员会在深入解析国内外学者研究成果,并由此广泛征求业内相关专家意见的基础上起草并制定了团体标准《人多能干细胞来源的小细胞外囊泡》与《人间充质干细胞来源的小细胞外囊泡》。这2项标准的制定将有助于规范并推动人干细胞来源sEVs研究与应用,并为其临床转化制剂制备提供参照标准。对这2项团体标准的重点条款进行解读,有助于相关专业技术人员更好的理解和应用该标准。

Small extracellular vesicles(sEVs)derived from human stem cells have shown significant therapeutic effects in preclinical studies for various diseases as a"stem cell-free therapy"and have gradually undergone multiple clinical trials.However,the quality attributes of sEVs derived from human stem cells currently lack unified standards,limiting their further clinical applications.Therefore,the Chinese Society for Extracellular Vesicles drafted and formulated group standards for"Requirements for human pluripotent stem cell-derived small extracellular vesicles"and"Human mesenchymal stem cell derived small extracellular vesicles"based on in-depth analysis of domestic and foreign scholars'results and extensive consultations with relevant industry experts.Developing these two standards will help standardize and promote the research and application of sEVs derived from human stem cells and provide reference standards for their clinical transformation preparation.Interpreting key provisions of these two group standards will help relevant technical professionals better understand and apply the standards.