类器官技术在新药临床试验研究中的应用现状  

Advances in the application of organoid technology in clinical trials of new drugs

作　　者：何嘉丽 谢翠莹 岑柏宏 古安城 姚香草 车津晶 许重远[1,2] HE Jia-li;XIE Cui-ying;CEN Bo-hong;GU An-cheng;YAO Xiang-cao;CHE Jin-jing;XU Zhong-yuan(Clinical Pharmacy Center,Nanfang Hospital,Southern Medical University,Guangzhou 510515,Guangdong Province,China;National Medical Products Administration Key Laboratory for Research and Evaluation of Drug Metabolism&Guangdong Provincial Key Laboratory of New Drug Screening,School of Pharmaceutical Sciences,Southern Medical University,Guangzhou 510515,Guangdong Province,China;State Key Laboratory of Toxicology and Medical Countermeasures,Beijing Institute of Pharmacology and Toxicology,Beijing 100850,China)

机构地区：[1]南方医科大学南方医院临床药学中心,广东广州510515 [2]南方医科大学国家药品监督管理局药物代谢研究与评价重点实验室及广东省新药筛选重点实验室,广东广州510515 [3]军事医学研究院毒物药物研究所抗毒药物与毒理学国家重点实验室,北京100850

出　　处：《中国临床药理学杂志》2023年第13期1967-1971,共5页The Chinese Journal of Clinical Pharmacology

基　　金：南方医科大学南方医院临床研究专项基金资助项目(2019CR015);南方医科大学南方医院院长基金资助项目(2022B043)。

摘　　要：类器官是一种在体外由干细胞或器官祖细胞诱导分化形成的三维结构的组织类似物,能够高度模拟体内器官的结构与功能,保留遗传和表观特征;其具良好的发展前景,有望推动疾病的临床研究,因而备受关注。近年来,类器官逐步被应用到临床试验中,助力新药研发。本文将介绍类器官的来源及其在新药临床试验中应用情况、相关法律法规的现况,总结类器官技术在新药临床试验研究应用的进展。Organoid is a self-organizing three-dimensional tissue analog produced from(pluripotent) stem cells,progenitor,and/or differentiated cells in vitro,which can highly mimic the structure and function of organs in vivo,preserving genetic and epigenetic characteristics.Due to its excellent developmental potential and capacity to support clinical research,it has garnered attention.And in recent years,organoids have been gradually applied to clinical trials to assist in the development of novel medications.This essay will introduce the sources and applications of organoids,describe the current state of relevant laws and regulations,and finally,outline the advancement of the use of organoid technology in clinical trial research of novel pharmaceuticals.

关 键 词：类器官 新药研发 临床试验 

分 类 号：R97[医药卫生—药品]