Xenotransplantation Research -the Nonhuman Primate Model Is Preferable to the Human Decedent Model

Over the past 40 years, the pig-to-nonhuman primate organ transplantation model has enabled progress in xenotransplantation to be made to the point that we are now carrying out initial US FDA-approved clinical experiments on “compassionate” grounds. More recently, the pig-to-human brain-dead deceden...

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Main Authors: D. K. C. Cooper, L. Mou, J. D. Cleveland, J. H. Simmons, D. C. Cleveland
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-08-01
Series:Transplant International
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Online Access:https://www.frontierspartnerships.org/articles/10.3389/ti.2025.14452/full
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author D. K. C. Cooper
L. Mou
J. D. Cleveland
J. H. Simmons
D. C. Cleveland
author_facet D. K. C. Cooper
L. Mou
J. D. Cleveland
J. H. Simmons
D. C. Cleveland
author_sort D. K. C. Cooper
collection DOAJ
description Over the past 40 years, the pig-to-nonhuman primate organ transplantation model has enabled progress in xenotransplantation to be made to the point that we are now carrying out initial US FDA-approved clinical experiments on “compassionate” grounds. More recently, the pig-to-human brain-dead decedent model was introduced with claims that this might replace (or at least augment) the pig-to-NHP model. There are, however, several limitations of the decedent model, most notably the very limited period during which the subject may remain sufficiently metabolically and hemodynamically stable to allow meaningful monitoring of the fate of a pig organ graft. It will be exceedingly difficult to provide the regulatory authorities with data from experiments in which truly prolonged graft function has been monitored, whereas this is already being achieved in the pig-to-NHP model. In view of the complications related to the effects of brain death, the data obtained from xenotransplantation experiments in decedents may provide confusing results. There is a real risk that this may influence the regulatory authorities to become overly cautious in approving formal clinical trials of pig organ xenotransplantation to be initiated. We conclude that experiments in human decedents will be unable to replace studies in pig-to-NHP models.
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institution Kabale University
issn 1432-2277
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publisher Frontiers Media S.A.
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series Transplant International
spelling doaj-art-e75284ade21e4fac841021adb2c12ffb2025-08-20T03:40:54ZengFrontiers Media S.A.Transplant International1432-22772025-08-013810.3389/ti.2025.1445214452Xenotransplantation Research -the Nonhuman Primate Model Is Preferable to the Human Decedent ModelD. K. C. Cooper0L. Mou1J. D. Cleveland2J. H. Simmons3D. C. Cleveland4Department of Surgery, Center for Transplantation Sciences, Massachusetts General Hospital/Harvard Medical School, Boston, MA, United StatesShenzhen Xenotransplantation Medical Engineering Research and Development Center, Shenzhen Institute of Translational Medicine, Health Science Center, The First Affiliated Hospital of Shenzhen University, Shenzhen Second People’s Hospital, Shenzhen, ChinaChildren’s Hospital of Los Angeles, University of Southern California, Los Angeles, CA, United StatesMichale E. Keeling Center for Comparative Medicine and Research, University of Texas MD Anderson Cancer Center, Bastrop, TX, United StatesChildren’s Hospital of Los Angeles, University of Southern California, Los Angeles, CA, United StatesOver the past 40 years, the pig-to-nonhuman primate organ transplantation model has enabled progress in xenotransplantation to be made to the point that we are now carrying out initial US FDA-approved clinical experiments on “compassionate” grounds. More recently, the pig-to-human brain-dead decedent model was introduced with claims that this might replace (or at least augment) the pig-to-NHP model. There are, however, several limitations of the decedent model, most notably the very limited period during which the subject may remain sufficiently metabolically and hemodynamically stable to allow meaningful monitoring of the fate of a pig organ graft. It will be exceedingly difficult to provide the regulatory authorities with data from experiments in which truly prolonged graft function has been monitored, whereas this is already being achieved in the pig-to-NHP model. In view of the complications related to the effects of brain death, the data obtained from xenotransplantation experiments in decedents may provide confusing results. There is a real risk that this may influence the regulatory authorities to become overly cautious in approving formal clinical trials of pig organ xenotransplantation to be initiated. We conclude that experiments in human decedents will be unable to replace studies in pig-to-NHP models.https://www.frontierspartnerships.org/articles/10.3389/ti.2025.14452/fullkidneyxenotransplantationbrain deathdecedentnonhuman primate
spellingShingle D. K. C. Cooper
L. Mou
J. D. Cleveland
J. H. Simmons
D. C. Cleveland
Xenotransplantation Research -the Nonhuman Primate Model Is Preferable to the Human Decedent Model
Transplant International
kidney
xenotransplantation
brain death
decedent
nonhuman primate
title Xenotransplantation Research -the Nonhuman Primate Model Is Preferable to the Human Decedent Model
title_full Xenotransplantation Research -the Nonhuman Primate Model Is Preferable to the Human Decedent Model
title_fullStr Xenotransplantation Research -the Nonhuman Primate Model Is Preferable to the Human Decedent Model
title_full_unstemmed Xenotransplantation Research -the Nonhuman Primate Model Is Preferable to the Human Decedent Model
title_short Xenotransplantation Research -the Nonhuman Primate Model Is Preferable to the Human Decedent Model
title_sort xenotransplantation research the nonhuman primate model is preferable to the human decedent model
topic kidney
xenotransplantation
brain death
decedent
nonhuman primate
url https://www.frontierspartnerships.org/articles/10.3389/ti.2025.14452/full
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AT lmou xenotransplantationresearchthenonhumanprimatemodelispreferabletothehumandecedentmodel
AT jdcleveland xenotransplantationresearchthenonhumanprimatemodelispreferabletothehumandecedentmodel
AT jhsimmons xenotransplantationresearchthenonhumanprimatemodelispreferabletothehumandecedentmodel
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