我国干细胞临床研究管理现状及对策思考  

Current Situation and Countermeasures for Clinical Research Management of Stem Cell in China

作　　者：黄小慧[1] 黄凯琪 张琪[1] 彭亮[1] HUANG Xiao-hui;HUANG Kai-qi;ZHANG Qi;PENG Liang(The Third Affiliated Hospital of Sun Yat-sen University,Guangzhou 510630,China)

机构地区：[1]中山大学附属第三医院,广州市510630

出　　处：《现代医院管理》2021年第1期21-25,共5页Modern Hospital Management

基　　金：中山大学附属第三医院管理科研基金(2019GLMS06)。

摘　　要：近年来,干细胞治疗已经成为一个极具发展前景的前沿科学研究领域,其治疗方法的发展给患者及家属带来了极大的期望。然而,随着我国干细胞临床研究项目数量的不断增加,干细胞临床研究与应用中存在的伦理和安全问题日益突出,使我国监督管理部门和研究机构面临着前所未有的挑战。本文通过分析我国干细胞临床研究的管理现状和存在的问题,探讨加强干细胞临床研究监督和研究机构内部管理规范的措施,为有效推进我国干细胞临床研究的有序、规范发展提出相应对策。In recent years,stem cell therapy has become a frontier scientific research field with great development prospects,and the development of its treatment methods has brought great expectations to patients and their families.However,with the continuous increase of the number of stem cell clinical research projects in China,the ethical and safety issues in clinical research and application of stem cells have become increasingly prominent,which has brought unprecedented challenges to the supervision and management departments,and research institutions in China.This paper analyzes the management status and the existing problems of stem cell clinical research in China,discusses the measures to strengthen the supervision of stem cell clinical research and the internal management of research institutions,and puts forward corresponding countermeasures to effectively promote the orderly and standardized development of stem cell clinical research in China.

关 键 词：干细胞 临床研究 管理 规范 

分 类 号：R197[医药卫生—卫生事业管理]