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中华移植杂志(电子版) ›› 2026, Vol. 20 ›› Issue (04) : 291 -297. doi: 10.3877/cma.j.issn.1674-3903.2026.04.012

移植前沿

猪-人异种器官移植临床研究要求及伦理审查对策
陈嵩涛1, 周吉银2,†()   
  1. 1850000 拉萨,拉萨市人民医院科教科
    2400037 重庆,陆军军医大学第二附属医院临床医学研究中心
  • 收稿日期:2026-06-09 出版日期:2026-08-25
  • 通信作者: 周吉银
  • 基金资助:
    2022年陆军军医大学人文社会科学基金重点项目(2022XRW02)

Clinical trial requirements and ethics review strategies of pig-to-human xenotransplantation

Songtao Chen1, Jiyin Zhou2,†()   

  1. 1Department of Science and Education, Lhasa People′s Hospital, Lhasa 850000, China
    2Clinical Medical Research Center, Second Affiliated Hospital, Army Medical University, Chongqing 400037, China
  • Received:2026-06-09 Published:2026-08-25
  • Corresponding author: Jiyin Zhou
引用本文:

陈嵩涛, 周吉银. 猪-人异种器官移植临床研究要求及伦理审查对策[J/OL]. 中华移植杂志(电子版), 2026, 20(04): 291-297.

Songtao Chen, Jiyin Zhou. Clinical trial requirements and ethics review strategies of pig-to-human xenotransplantation[J/OL]. Chinese Journal of Transplantation(Electronic Edition), 2026, 20(04): 291-297.

2025年2月,美国食品药品监督管理局批准首次人体异种器官移植临床试验,标志着异种器官移植将从临床前研究、亚临床研究,进入临床试验。我国已制订异种器官移植临床研究指导意见和亚临床研究专家共识,并于2026年4月底发布《异种移植新技术临床研究备案指引(第1版)》。异种器官移植临床研究需考虑临床前研究(非人灵长类动物存活时间和亚临床研究)数据要求、临床研究设计、纳入排除标准、知情同意、社会心理评估和支持,以及长期监测异种器官移植的研究参与者。为确保异种器官移植临床研究的伦理审查质量,需加强审查异种器官移植临床研究的伦理委员会建设和培训,明确伦理审查要点,严格评估风险获益比。明确异种器官移植临床研究及其伦理审查的具体要求,将有助于维护异种器官移植研究参与者的安全和权益,促进异种器官移植临床研究的健康发展。

In February 2025, U. S. Food and Drug Administration approved the first human xenotransplantation clinical trial, signaling that xenotransplantation will move from preclinical research and subclinical trials to clinical trials. China has formulated guidelines for clinical trials on xenotransplantation and expert consensus on subclinical trails, at the end of April 2026, the " Guidelines for the Clinical Research Filing of New Xenotransplantation Technologies (First Edition)" were released. Xenotransplantation clinical trials need to consider the requirements of data from preclinical researches (non-human primate survival time and subclinical trials), clinical trial design, defense of the selection of inclusion and exclusion criteria, informed consent, psychosocial assessment and support, and long-term monitoring of xenotransplantation participants. In order to ensure the quality of ethics review of xenotransplantation clinical trials, it is necessary to include the strengthening of ethics committees for reviewing xenotransplantation clinical trials, the training of ethics committees′ members and secretaries, the clarification of the key points of ethics review, and the rigorous assessment of risk-benefit ratios. These specific requirements for xenotransplantation clinical trials and their ethics review will help safeguard the safety and rights of xenotransplantation participants and escort the healthy and rapid development of their clinical trials.

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