Organ transplants of the future: planning for innovations including xenotransplantation

E. Cozzi; Stefan Schneeberger; Maria Irene Bellini; Erik Berglund; Georg Bohmig; Kevin Fowler; Martin Hoogduijn; Ina Jochmans; Georg Marckmann; Lorna P Marson; James Neuberger; Rainer Oberbauer; Richard N. Pierson III; Bruno Reichart; Linda Scobie; Colin White; Martin Naesens

doi:10.1111/tri.14031

Organ transplants of the future: planning for innovations including xenotransplantation

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

Research output: Contribution to journal › Article › peer-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 language	English
Journal	Transplant international
DOIs	https://doi.org/10.1111/tri.14031
Publication status	Published - 28 Aug 2021

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Cozzi et al 2906 cleanAccepted author manuscript, 1.56 MB

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Cozzi, E., Schneeberger, S., Bellini, M. I., Berglund, E., Bohmig, G., Fowler, K., Hoogduijn, M., Jochmans, I., Marckmann, G., Marson, L. P., Neuberger, J., Oberbauer, R., Pierson III, R. N., Reichart, B., Scobie, L., White, C., & Naesens, M. (2021). Organ transplants of the future: planning for innovations including xenotransplantation. Transplant international. https://doi.org/10.1111/tri.14031

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title = "Organ transplants of the future: planning for innovations including xenotransplantation",

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. ",

author = "E. Cozzi and Stefan Schneeberger and Bellini, {Maria Irene} and Erik Berglund and Georg Bohmig and Kevin Fowler and Martin Hoogduijn and Ina Jochmans and Georg Marckmann and Marson, {Lorna P} and James Neuberger and Rainer Oberbauer and {Pierson III}, {Richard N.} and Bruno Reichart and Linda Scobie and Colin White and Martin Naesens",

year = "2021",

month = aug,

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doi = "10.1111/tri.14031",

language = "English",

journal = "Transplant international",

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Cozzi, E, Schneeberger, S, Bellini, MI, Berglund, E, Bohmig, G, Fowler, K, Hoogduijn, M, Jochmans, I, Marckmann, G, Marson, LP, Neuberger, J, Oberbauer, R, Pierson III, RN, Reichart, B, Scobie, L, White, C & Naesens, M 2021, 'Organ transplants of the future: planning for innovations including xenotransplantation', Transplant international. https://doi.org/10.1111/tri.14031

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T1 - Organ transplants of the future: planning for innovations including xenotransplantation

AU - Cozzi, E.

AU - Schneeberger, Stefan

AU - Bellini, Maria Irene

AU - Berglund, Erik

AU - Bohmig, Georg

AU - Fowler, Kevin

AU - Hoogduijn, Martin

AU - Jochmans, Ina

AU - Marckmann, Georg

AU - Marson, Lorna P

AU - Neuberger, James

AU - Oberbauer, Rainer

AU - Pierson III, Richard N.

AU - Reichart, Bruno

AU - Scobie, Linda

AU - White, Colin

AU - Naesens, Martin

PY - 2021/8/28

Y1 - 2021/8/28

N2 - 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.

AB - 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.

U2 - 10.1111/tri.14031

DO - 10.1111/tri.14031

M3 - Article

JO - Transplant international

JF - Transplant international

SN - 0934-0874

ER -

Organ transplants of the future: planning for innovations including xenotransplantation

Abstract

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