基于ClinicalTrials.gov及WHO ICTRP的中日诱导多能干细胞临床研究现状的比较研究  

Comparative study on the current status of induced pluripotent stem cells clinical research in China and Japan based on ClinicalTrials.gov and WHO ICTRP

作　　者：杜慧 肖宇锋[1] 张玢[1] DU Hui;XIAO Yufeng;ZHANG Bin(Institute of Medical Information,Chinese Academy of Medical Sciences,Beijing100005,China)

机构地区：[1]中国医学科学院医学信息研究所,北京100005

出　　处：《中国医药导报》2024年第28期32-36,共5页China Medical Herald

基　　金：中国工程科技知识中心建设项目(CKCEST-2023-1-15)。

摘　　要：目的基于ClinicalTrials.gov和WHO ICTRP比较研究中日诱导多能干细胞(iPSC)的临床研究现状。方法检索ClinicalTrials.gov和WHO ICTRP平台,对建库至2024年3月中日iPSC临床试验数据进行采集,利用文献计量学方法,从注册数量、申办机构、疾病分类和研究类型及分期等角度,对中日该领域的临床试验注册现状进行比较研究。结果中国注册iPSC临床试验15项,日本53项;中日临床试验申办者均以高校、医院等科研院所为主,中国企业表现也较为活跃;中国临床试验覆盖的疾病范围小于日本;中日两国临床试验均以实验性研究为主。结论中国的iPSC技术还有较大的发展空间,未来发展需要进一步完善监管政策,建立严格的质量控制体系,合理规划和建设临床级i PS细胞库,综合高校、科研院所、企业三者iPSC研发与应用优势,加强资源合作,促进技术成果转化,推动技术的进步和应用的拓展。Objective To compare the current status of clinical research on induced pluripotent stem cells(iPSC)between China and Japan,based on data from ClinicalTrials.gov and WHO ICTRP.Methods Clinical trials of iPSC were retrieved in ClinicalTrials.gov and WHO ICTRP from the database establishment to March 2024.The data were extracted and analyzed including the registration numbers,sponsors,disease classifications,study type’and stage.Results Fifteen iPSC clinical trials were registered in China,compared to fifty-three in Japan.Both countries’clinical trials were primarily sponsored by universities and medical institutions,with Chinese companies also playing an active role.The range of diseases covered by clinical trials in China was smaller than that in Japan.Both countries primarily conducted experimental studies.Conclusion iPSC technology in China still has considerable room for development.In the future,it is necessary to further improve regulatory policies,establish a strict quality control system,construct clinical-grade iPS cell banks,integrate the advantages of iPSC and application of universities,research institutes,and enterprises to strengthen resource cooperation,promote the transformation of technological achievements,and drive the advancement and expansion of the technology’s application.

关 键 词：诱导多能干细胞 ClinicalTrials.gov WHO ICTRP 临床试验 文献计量 

分 类 号：R329[医药卫生—人体解剖和组织胚胎学]