TY - JOUR
T1 - Organ transplants of the future: planning for innovations including xenotransplantation
AU - Cozzi, Emanuele
AU - Schneeberger, Stefan
AU - Bellini, Maria Irene
AU - Berglund, Erik
AU - Böhmig, Georg
AU - Fowler, Kevin
AU - Hoogduijn, Martin
AU - Jochmans, Ina
AU - Marckmann, Georg
AU - Marson, Lorna
AU - Neuberger, James
AU - Oberbauer, Rainer
AU - Pierson III, Richard N.
AU - Reichart, Bruno
AU - Scobie, Linda
AU - White, Colin
AU - Naesens, Maarten
AU - ESOT Workstream 1 of the TLJ (Transplantation Learning Journey) Project
N1 - Acceptance in SharePoint
AAM: 12m embargo
PY - 2021/11
Y1 - 2021/11
N2 - The future clinical application of animal-to-human transplantation (xeno-transplantation) 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 over-view 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.
AB - The future clinical application of animal-to-human transplantation (xeno-transplantation) 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 over-view 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.
KW - clinical study design, innovation, patient centred, machine perfusion, endpoints, regulation
KW - organ shortage
U2 - 10.1111/tri.14031
DO - 10.1111/tri.14031
M3 - Article
VL - 34
SP - 2006
EP - 2018
JO - Transplant International
JF - Transplant International
SN - 0934-0874
IS - 11
ER -