人间充质干细胞质量研究及评价进展

Research progress in quality research and evaluation of human mesenchymal stem cells

人间充质干细胞(hMSCs)作为成体干细胞,具有自我复制更新及多向分化潜能,独特的生物学功能决定其广泛的临床适应症,研究者可根据临床预期目标定义hMSCs的质量属性,其质量研究一般应考虑hMSCs的微生物学安全性、生物学安全性、细胞生物学属性及生物学有效性。质量评价是针对hMSCs各质量属性所建立起的、具有共识性的各类物理、化学及生物学评价方法。传统产品安全性评价策略无法完全适应当下工艺和产品使用特性,研究者已结合当前技术开发有效评价的新方法;产品有效性评价策略根据临床预期用途并在质量研究基础上,已逐步建立和规范有效性评价体系,使研究者更全面评价不同阶段和工艺下的hMSCs产品。主要对人间充质干细胞质量研究及评价的研究进展进行综述,为发挥干细胞在再生医学领域的应用提供参考。

As adult stem cells,human mesenchymal stem cells(hMSCs)have the potential for self-replication,renewal,and multidirection differentiation.Their unique biological function determines their wide clinical indications.Researchers can define the quality attributes of hMSCs according to clinical expectations.The quality study of hMSCs should consider microbiological safety,biological safety,cell biological properties,and biological effectiveness.Quality evaluation is a common physical,chemical,and biological evaluation method for hMSCs.Traditional product safety evaluation strategies cannot fully adapt to current technology and product usage characteristics.Researchers have developed new,effective evaluation methods based on current technology.In terms of product efficacy evaluation strategies,an efficacy evaluation system has been gradually established and standardized according to the intended clinical use and based on quality studies,which can enable researchers to evaluate hMSCs products more comprehensively at different stages and processes.In this paper,the progress of quality research and evaluation of human mesenchymal stem cells was reviewed to provide a reference for the utilization of stem cells in the field of regenerative medicine.