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

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. © 2017 christopher g. a. mcgregor and guerard w. byrne.