中文摘要：

间充质干细胞（mesenchymal stem cell,MSC）是一类具有自我更新/多向分化潜能和独特免疫调控功能的成体干细胞,并已成为近年来临床研究中发展最为迅速的干细胞类型。由于其独特的免疫调控功能,MSC已被用于治疗多种类型的免疫异常或炎症反应失控所致的疾病。MSC在不同类型的炎症环境中,可由静息状态转变成激活状态,通过细胞间相互作用和分泌可溶性免疫调控因子,调节多种免疫细胞的增殖、分化、活化以及炎症因子的分泌功能。MSC的免疫调控功能是其临床应用中重要的生物学有效性质量属性,对这一质量属性的有效评价,是指导MSC产品研发及临床应用中最为相关的质量控制内容之一。本文综述了近年来人们对MSC免疫调控功能的认识及其与临床应用的相关性,在此基础上提出了针对治疗性MSC产品免疫调控功能的评价策略,为在我国建立和完善MSC生物学有效性评价体系奠定基础。

英文摘要：

Mesenchymal stem cells（ MSCs） are a group of adult stem cells with capabilities of self-renewing and multiple differentiation potentials,which have unique immunomodulatory properties. They represent the cell type being fastest developed among all the stem cells used in clinical studies. Because of the unique immunomodulatory properties,human MSCs have been tested for their therapeutic effects on a vast variety of diseases which are commonly associated with derailed immune responses or uncontrolled inflammation. Within damaging or inflammatory environment,MSCs can be activated to regulate the immune system by modulating activities of proliferation,differentiation,activation and / or secretion of almost all types of immune cells. Such immunomodulatory activities are achieved through direct interaction between MSCs and immune cells as well as secretion of different immunomodulatory molecules. The immunomodulatory function has been considered as the critical quality attribute contributing to the biological effectiveness of MSC-based products. Thus assessment of this function represents a substantial part of the quality control testing during both pre-clinical and clinical studies. Through highlighting,in this article,the recent advances in understanding of the immunomodulatory properties of MSCs and its implications in clinical studies,we hope to establish appropriate assessment technologies and strategies for effectively evaluating biological effectiveness of MSC-based products. This will guide eventual establishment of comprehensive quality control system for the products in China.