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 utilising genetic engineering and protocols of pathogen-free husbandry. Findings have reached a tipping point and xenotransplantation of solid organs is approaching its clinical application; this 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 Workstream 01 of the Transplantation Learning Journey project, a programme of the European Society for Organ Transplantation. 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.
- clinical study design, innovation, patient centred, machine perfusion, endpoints, regulation