异种器官移植亚临床研究专家共识(2024版)  

Expert consensus on subclinical research of xenotransplantation(2024 edition)

作　　者：中华医学会器官移植学分会异种移植学组 窦科峰 陶开山 张玄 宋俊伯 Xenotransplantation Group of Branch of Organ Transplantation of Chinese Medical Association;Dou Kefeng;Tao Kaishan(不详;Xijing Hospital of Air Force Medical University,Xi’an 710032,China)

机构地区：[1]不详 [2]空军军医大学西京医院,西安710032

出　　处：《器官移植》2024年第5期653-660,共8页Organ Transplantation

基　　金：国家自然科学基金面上项目(82371793、82070671、82170667)。

摘　　要：异种器官移植亚临床研究是利用脑死亡受者进行的异种器官移植试验,是异种器官移植从基础研究和动物实验,逐步走向临床应用的重要中间环节,为异种移植的安全性和有效性提供了必要的数据支撑。为推进异种器官移植亚临床研究安全有序、科学规范地开展,根据相关法律和规范,中华医学会器官移植学分会异种移植学组从供体猪的选择、受者的选择标准、法律法规及伦理要求、试验终止时间的确定、家属知情同意制度、脑死亡判定标准等方面,制定了《异种器官移植亚临床研究专家共识(2024版)》。Subclinical research of xenotransplantation involves xenotransplantation trial using brain death donors,which is an important intermediate step from basic research and animal experiments to the clinical application of xenotransplantation.It provides necessary data support for the safety and efficacy of xenotransplantation.In order to promote the safe,orderly,scientific and standardized development of subclinical research on xenotransplantation,the Xenotransplantation Group of Branch of Organ Transplantation of Chinese Medical Association formulated the“Expert Consensus on Subclinical Research of Xenotransplantation(2024 Edition)”based on relevant laws and regulations.The consensus includes aspects such as the selection of donor pigs,recipient selection criteria,legal and ethical requirements,determination of trial termination time,family informed consent system,and brain death determination standards.

关 键 词：异种移植 器官移植 亚临床研究 脑死亡 基因修饰猪 法律法规 医学伦理 非人灵长类动物 

分 类 号：R617[医药卫生—外科学] Q78[医药卫生—临床医学]