Organ transplants of the future: planning for innovations including xenotransplantation

Emanuele Cozzi, Stefan Schneeberger, Maria Irene Bellini, Erik Berglund, Georg Böhmig, Kevin Fowler, Martin Hoogduijn, Ina Jochmans, Georg Marckmann, Lorna Marson, James Neuberger, Rainer Oberbauer, Richard N. Pierson III, Bruno Reichart, Linda Scobie, Colin White, Maarten Naesens*,

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

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.
Original languageEnglish
JournalTransplant International
Early online date28 Aug 2021
DOIs
Publication statusE-pub ahead of print - 28 Aug 2021

Keywords

  • clinical study design, innovation, patient centred, machine perfusion, endpoints, regulation

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