Porcine to Human Heart Transplantation: Is Clinical Application Now Appropriate?

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Cardiac xenotransplantation (CXTx) is a promising solution to the chronic shortage of donor hearts. Recent advancements in immune suppression have greatly improved the survival of heterotopic CXTx, now extended beyond 2 years, and life-supporting kidney XTx. Advances in donor genetic modification (B4GALNT2 and CMAH mutations) with proven Gal-deficient donors expressing human complement regulatory protein(s) have also accelerated, reducing donor pig organ antigenicity. These advances can now be combined and tested in life-supporting orthotopic preclinical studies in nonhuman primates and immunologically appropriate models confirming their efficacy and safety for a clinical CXTx program. Preclinical studies should also allow for organ rejection to develop xenospecific assays and therapies to reverse rejection. The complexity of future clinical CXTx presents a substantial and unique set of regulatory challenges which must be addressed to avoid delay; however, dependent on these prospective life-supporting preclinical studies in NHPs, it appears that the scientific path forward is well defined and the era of clinical CXTx is approaching.

Original languageEnglish (US)
Article number2534653
JournalJournal of Immunology Research
StatePublished - 2017
Externally publishedYes

Bibliographical note

Funding Information:
This study is supported by the NIH Grant AI66310, the MRC Grant MR L013193, and the NIHR UCL Biomedical Research Centre.

Publisher Copyright:
© 2017 Christopher G. A. McGregor and Guerard W. Byrne.


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