干细胞基础研究和临床研究的现状分析

Basic and clinical research on stem cells:current status

目的了解近5年干细胞领域基础研究与临床转化现状,为相关领域学科发展提供参考。方法干细胞基础研究部分,于2020年5月15日检索Web of Science核心合集数据库中2015年至2020年干细胞相关文献,选择该领域的高被引论文及热点论文共计1954篇,通过CiteSpace软件进行关键词分析和聚类分析。干细胞临床研究部分,于2020年5月23日检索美国临床试验数据库(ClinicalTrials.gov)及国家药品监督管理局药品审评中心、中国医药生物技术协会官方网站公布的数据,利用Excel 2007进行汇总整理。结果在基础研究方面,“表达”“分化”“多能干细胞”“T细胞”和“祖细胞”为干细胞研究的热点,并聚类为“胚胎干细胞”“肿瘤干细胞”“抗宿主病”“细胞来源外泌体”“骨组织工程”“克隆性造血”和“创伤性脑损伤”7个主题。在临床研究方面,检索到全球有5506项干细胞相关临床试验,其中我国有482项。全球已批准上市的干细胞产品有18个,以间充质干细胞为主,国内干细胞产品尚处于临床试验阶段。国内已完成备案的73项干细胞临床研究项目中约2/3(49项)为间充质干细胞相关项目,33项(45.2%)涉及脐带来源间充质干细胞,研究疾病类型主要有银屑病、狼疮性肾炎、急性心肌梗死、骨关节炎等。结论对于干细胞研究热点和7个热点主题领域应予以关注。无论是全球已上市的干细胞产品,还是国内开展的干细胞临床研究均以间充质干细胞居多。

Objective To understand the current status of basic research and clinical translation in the field of stem cells in recent 5 years,so as to provide reference for the development of related disciplines.Methods(1)Basic research on stem cells:stem cell related literatures published between 2015 and 2020 were retireved from Web of Science Core Collection datebase on May 15,2020,1954 highly cited papers and hot papers in this filed were selected,and keyword analysis and cluster analysis were conducted through CiteSpace.(2)Clinical research:the data were searched on ClinicalTrials.gov,and official websites of the Center for Drug Evaluation of National Medical Products Administration and China Medicinal Biotech Association on May 23,2020,summarized and sorted by Excel 2007.Results For basic research,“expression”,“differentiation”,“pluripotent stem cell”,“T cell”and“progenitor cell”were focuses of stem cell research,and they were clustered into 7 themes:“embryonic stem cell”,“cancer stem cell”,“versus-host disease”,“cell-derived exosome”,“bone tissue engineering”,“clonal hematopoiesis”and“traumatic brain injury”.For clinical research,5506 stem cell related clinical trials were retrieved worldwide,including 482 in China.There were 18 stem cell products approved for marketing in the world,mainly focusing on mesenchymal stem cells,and domestic stem cell products were still in the stage of clinical trial.Of the 73 stem cell clinical research projects registered in China,about 2/3(49 projects)were mesenchymal stem cell related projects,33 projects(45.2%)involved umbilical cord derived mesenchymal stem cells.The main types of diseases included psoriasis,lupus nephritis,acute myocardial infarction,osteoarthritis,etc.Conclusion We should pay attention to the stem cell research focuses and its 7 focus areas.The stem cell products which have been approved to the world market and the clinical studies of stem cells carried out in China are mostly focused on mesenchymal stem cells.