干細胞研究和臨床試驗發(fā)展迅速，目前全球干細胞臨床研究排名前三的國家或地區(qū)分別是美國、歐洲和中國，干細胞治療種類以造血干細胞為主，間充質(zhì)干細胞日益增長，神經(jīng)干細胞和多能干細胞的臨床試驗也相對較多。目前全球已有14款干細胞藥物上市，超過一半以上是間充質(zhì)干細胞治療產(chǎn)品。中國共有87個干細胞臨床項目完成備案，其中間充質(zhì)干細胞備案項目最多。細胞治療是按照醫(yī)療技術還是藥品來監(jiān)管，世界各國有所不同。在美國按細胞組織類產(chǎn)品風險高低進行歸類監(jiān)管，歐盟以先進技術治療醫(yī)學產(chǎn)品歸類監(jiān)管，日本按照再生醫(yī)學產(chǎn)品管理，中國目前進行機構和項目雙備案制度。在嚴格分類管理的基礎上，無論歐盟的醫(yī)院豁免制度、日本的條件限制性準入政策，還是中國從藥品-第三類醫(yī)療技術-備案制管理政策的變遷，都為干細胞及其他細胞治療產(chǎn)品的研究和應用提供了科學而快速發(fā)展的政策保障。對國內(nèi)外干細胞臨床研究及應用的發(fā)展現(xiàn)狀進行綜述，同時分析各國干細胞臨床研究相關的法律法規(guī)與質(zhì)量控制監(jiān)管政策。

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.

R926

國家科技重大專項課題——重大新藥創(chuàng)制（2016ZX09101094）；北京市科委企業(yè)技術創(chuàng)新平臺建設（Z181100000518028）