干细胞临床研究及管理的现状与未来

干细胞研究和临床试验发展迅速，目前全球干细胞临床研究排名前三的国家或地区分别是美国、欧洲和中国，干细胞治疗种类以造血干细胞为主，间充质干细胞日益增长，神经干细胞和多能干细胞的临床试验也相对较多。目前全球已有14款干细胞药物上市，超过一半以上是间充质干细胞治疗产品。中国共有87个干细胞临床项目完成备案，其中间充质干细胞备案项目最多。细胞治疗是按照医疗技术还是药品来监管，世界各国有所不同。在美国按细胞组织类产品风险高低进行归类监管，欧盟以先进技术治疗医学产品归类监管，日本按照再生医学产品管理，中国目前进行机构和项目双备案制度。在严格分类管理的基础上，无论欧盟的医院豁免制度、日本的条件限制性准入政策，还是中国从药品-第三类医疗技术-备案制管理政策的变迁，都为干细胞及其他细胞治疗产品的研究和应用提供了科学而快速发展的政策保障。对国内外干细胞临床研究及应用的发展现状进行综述，同时分析各国干细胞临床研究相关的法律法规与质量控制监管政策。

Current status and future of stem cell clinical research and management

Stem cell research and clinical trials have developed rapidly. Nowadays,the top three countries or regions in the global clinical research on stem cells are the United States, Europe and China respectively. Hematopoietic stem cells are the main types of stem cell therapy, mesenchymal stem cells are growing increasingly, and clinical trials on neural stem cells and pluripotent stem cells are relatively large. Currently, 14 stem cell drugs have been marketed globally, more than half of which are mesenchymal stem cell therapy products. A total of 87 stem cell clinical projects have been registered in China, among which mesenchymal stem cells have the largest number. Whether cell therapy is regulated as a medical technology or as a drug varies around the world. In the United States, they are classified and regulated according to the risk level of cellular tissue products. In the European Union, they are classified and regulated as advanced therapy medicinal products (ATMPs). In Japan, they are regulated as regenerative medicine products. On the basis of strict classified management, the hospital exemption system of EU, the conditional and restrictive access policy of Japan, and the change of the management policy from drug-third class medical technology-record system in China all provide a scientific and rapid policy guarantee for the research and application of stem cells and other cell therapeutic products. This paper reviews the development status of stem cell clinical research and application at home and abroad, and analyzes the relevant laws and regulations and quality control regulatory policies of stem cell clinical research in various countries.