Department of Cardiac, Thoracic and Vascular Sciences and Public Health, Transplant Immunology Unit, Padua University Hospital, Padua, Italy.
Department of Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.
Transpl Int. 2021 Nov;34(11):2006-2018. doi: 10.1111/tri.14031. Epub 2021 Oct 6.
The future clinical application of animal-to-human transplantation (xenotransplantation) is of importance to society as a whole. Favourable preclinical data relevant to cell, tissue and solid organ xenotransplants have been obtained from many animal models utilizing genetic engineering and protocols of pathogen-free husbandry. Findings have reached a tipping point, and xenotransplantation of solid organs is approaching clinical evaluation, the process of which now requires close deliberation. Such discussions include considering when there is sufficient evidence from preclinical animal studies to start first-in-human xenotransplantation trials. The present article is based on evidence and opinions formulated by members of the European Society for Organ Transplantation who are involved in the Transplantation Learning Journey project. The article includes a brief overview of preclinical concepts and biology of solid organ xenotransplantation, discusses the selection of candidates for first-in-human studies and considers requirements for study design and conduct. In addition, the paper emphasizes the need for a regulatory framework for xenotransplantation of solid organs and the essential requirement for input from public and patient stakeholders.
动物到人类的移植（异种移植）的未来临床应用对整个社会都具有重要意义。通过利用基因工程和无病原体饲养方案，许多动物模型已经获得了与细胞、组织和实体器官异种移植相关的有利的临床前数据。研究结果已经达到了一个临界点，实体器官的异种移植即将进入临床评估，这一过程现在需要仔细考虑。此类讨论包括考虑何时有充分的临床前动物研究证据开始首例人类异种移植试验。本文基于参与移植学习之旅项目的欧洲器官移植学会成员提出的证据和意见。文章简要概述了实体器官异种移植的临床前概念和生物学，讨论了首例人体研究候选者的选择，并考虑了研究设计和实施的要求。此外，本文强调了需要建立实体器官异种移植的监管框架，以及需要来自公众和患者利益相关者的投入。
