干细胞临床研究的进展与展望  

Progress and prospect of stem cells clinical research

作　　者：吴明兰 吴梅佳 翟优 刘健[1,2] WU Ming-lan;WU Mei-jia;ZHAI You;LIU Jian(Research Center for Clinical Pharmacy,Department of Clinical Pharmacy,The First Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou 310003,Zhejiang Province,China;Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research,Hangzhou 310003,Zhejiang Province,China)

机构地区：[1]浙江大学医学院附属第一医院临床药学部临床药学研究中心,浙江杭州310003 [2]浙江省药物临床研究与评价技术重点实验室,浙江杭州310003

出　　处：《中国临床药理学杂志》2023年第10期1511-1515,共5页The Chinese Journal of Clinical Pharmacology

基　　金：浙江省药学会医院药学专项科研基金资助项目(2021ZYY09)。

摘　　要：干细胞具有自我更新与多向分化的生物学特性。近年来,干细胞研究发展迅速,在组织器官修复与再生、解决重大难治性疾病等方面带来了新的希望,引起人们的广泛关注。我国干细胞研究也如火如荼,中国在这个领域已然进入到世界前列。然而,目前干细胞的体外和体内功能及其分化功能、临床应用的安全性和有效性尚不明确,因此存在较大风险,也极有可能引发伦理危机。本文对国内外干细胞临床研究进展进行综述,介绍目前开展最多的间充质干细胞临床研究领域的进展,并对干细胞研究中面临的风险和未来发展前景进行展望,以期对中国干细胞临床研究及应用规范有序地开展提供有益借鉴。Stem cells have the biological characteristics of self-renewal and multi-lineage differentiation.In recent years,the rapid development of stem cell research has brought new hope in tissue repair and regeneration,as well as novel therapies of major intractable diseases,which has aroused widespread attention.China has made considerable progress in the research of stem cells,which ranks at the forefront in the world.However,the in vitro and in vivo functions of stem cells,their differentiation function,and the safety and effectiveness in clinical practice are still unclear.Therefore,they are thought to have ethical and technical concerns.In this review,we focused on global recent advances in stem cell therapies and the clinical trials of mesenchymal stem cells(MSCs)which are the most widely used stem cells.The development prospects and challenges associated with stem cell were also analysed in order to provide important information for the standardized and orderly development of clinical research and application of stem cells in China.

关 键 词：干细胞 临床研究 伦理 立法监管 挑战 展望 

分 类 号：R97[医药卫生—药品]