中国干细胞临床备案研究现状

Current status of clinical stem cell research in China

干细胞是一类具有自我更新和分化能力的细胞,可以被诱导分化成为不同的细胞、组织和器官,为许多重大疾病的治疗提供了新的思路和工具.为进一步规范干细胞临床试验研究活动,我国卫计委、药监局组织制定了干细胞临床备案研究的相关规范,截至2020年3月19日已先后审批备案了74项干细胞临床研究,对干细胞制剂制备和临床研究全过程进行着质量管理和风险管控.本文按不同的干细胞类型、涉及的疾病种类梳理了中国干细胞临床备案研究项目,统计、整理、分析了中国干细胞临床研究项目备案的现状及特点.

Stem cells show biological features of self-renewal and differentiation ability and can differentiate into various cells,tissues or organs,providing fresh ideas for the treatment of severe diseases.In order to further standardize clinical stem cell researches,National Health and Family Planning Commission and State Drug Administration of PRC have formulated relevant standards,carrying out quality management and risk control for the whole process.As of March 19,2020,74 clinical stem cell researches have been successively approved and filed in China.In accordance with stem cell types and diseases involved,this article sorts out the clinical stem cell projects in China,and then analyses thesituation and characteristics.