Organ transplants of the future: planning for innovations including xenotransplantation.
clinical study design
endpoints
innovation
organ shortage
patient centred
regulation
Journal
Transplant international : official journal of the European Society for Organ Transplantation
ISSN: 1432-2277
Titre abrégé: Transpl Int
Pays: Switzerland
ID NLM: 8908516
Informations de publication
Date de publication:
Nov 2021
Nov 2021
Historique:
revised:
10
08
2021
received:
30
06
2021
accepted:
24
08
2021
pubmed:
31
8
2021
medline:
15
12
2021
entrez:
30
8
2021
Statut:
ppublish
Résumé
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.
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
2006-2018Subventions
Organisme : NIAID NIH HHS
ID : R01 AI143887
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI153612
Pays : United States
Organisme : European Society for Organ Transplantation (ESOT)
Informations de copyright
© 2021 Steunstichting ESOT. Published by John Wiley & Sons Ltd.
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