Abstract

Two of the greatest challenges facing kidney transplantation are the lack of donated organs and inequities in who receives a transplant. Xenotransplantation holds promise as a treatment approach that could solve the supply problem. Major advances in gene-editing procedures have enabled several companies to raise genetically-engineered pigs for organ donation. These porcine organs lack antigens and have other modifications that should reduce the probability of immunological rejection when transplanted into humans. The FDA and transplant leaders are starting to chart a path to test xenotransplantation in clinical trials and later integrate it into routine clinical care. We provide a framework that industry, regulatory authorities, payers, transplant professionals, and patient groups can implement to promote equity during every stage in this process. We also call for immediate action. Companies developing xenotransplantation technology should assemble patient advocacy boards to bring the concerns of individuals with ESKD front-and-center. For trials, xenotransplantation companies should partner with transplant programs with substantial patient populations of racial and ethnic minorities and that have reciprocal relationships with those communities. Those companies and transplant programs should reach out now to those communities, to inform them about xenotransplantation, and try to address their concerns. These actions have the potential to make these communities full partners in the promise of xenotransplantation.

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