中国MSC临床试验注册阶段性特征调查分析

目的 基于中国临床试验注册中心平台，分析探讨间充质干细胞（mesenchymal stem cell，MSC）临床试验研究在我国的特点及发展趋势。方法 通过在中国临床试验注册中心数据库进行检索，将2007年建库起至2022年4月的所有与MSC相关的临床试验项目纳入统计，对项目名称、研究所涉疾病/系统、研究所处阶段、注册时间、注册状态、研究负责单位地域分布等信息进行整理分析。结果 共有197项MSC相关临床试验纳入统计，注册数量整体呈逐年增加趋势；注册地集中在北京、上海、广东等地；经费以医院资助、地方财政、国家财政资金为主；项目研究以脐带为间充质干细胞主要来源，共涉及11个类别的系统相关疾病。结论 现阶段，MSC临床试验数目呈递增趋势，但存在地区间的不均衡性；我国干细胞研究者的临床试验注册观念正逐步建立，且已意识到临床注册的重要性，未来将持续促进MSC治疗的规范化和临床应用转化。

Investigation and analysis of the phased characteristics of MSC clinical trial registration in China

Objective To analyze the mesenchymal stem cell (MSC) clinical trial registered on the platform of the China Clinical Trial Registry, and discuss the characteristics and development trends of MSC clinical trial research in China. Methods By searching the database of Chinese Clinical Trial Registry, we included all MSC related clinical trials from the establishment of the database to April 2022 into the statistics. The project name, the disease/system involved in the study, the stage of the study, the registration time, the registration status, the geographical distribution of the responsible research units and other information were collected and analyzed. Results A total of 197 MSC related clinical trials were included in the statistics, and the overall number of registrations showed an increasing trend year by year; registered clinical trials were centred in Beijing, Shanghai, Guangdong; local finance, hospital subsidies and national financial funds were the major sources of funding; the project research takes umbilical cord as the main source of mesenchymal stem cells, involving a total of 11 categories of system-related diseases. Conclusion At current stage, the number of MSC clinical trials is increasing, but there is an imbalance between regions; Chinese stem cell researchers are gradually establishing the concept of clinical trial registration, and have realized the importance of clinical registration. In future, they will continue to promote the standardization of MSC treatment and the transformation of clinical applications.