Consistent survival in consecutive cases of life-supporting porcine kidney xenotransplantation using 10GE source pigs

Author:

Eisenson DanielORCID,Hisadome Yu,Santillan MichelleORCID,Iwase Hayato,Chen WeiLi,Shimizu AkiraORCID,Schulick Alex,Gu Du,Akbar Armaan,Zhou Alice,Koenig Kristy,Kuravi Kasinath,Rahman Farzana,Sorrells Lori,Burdorf Lars,DeSmet Kristina,Warren Daniel,Peterson Leigh,Lorber Marc,Ayares David,Cameron Andrew,Yamada KazuhikoORCID

Abstract

AbstractXenotransplantation represents a possible solution to the organ shortage crisis and is an imminent clinical reality with long-term xenograft survival in pig-to-nonhuman primate (NHP) heart and kidney large animal models, and short-term success in recent human decedent and clinical studies. However, concerns remain about safe clinical translation of these results, given the inconsistency in published survival as well as key differences between preclinical procurement and immunosuppression and clinical standards-of-care. Notably, no studies of solid organ pig-to-NHP transplantation have achieved xenograft survival longer than one month without CD40/CD154 costimulatory blockade, which is not currently an FDA-approved immunosuppression strategy. We now present consistent survival in consecutive cases of pig-to-NHP kidney xenotransplantation, including long-term survival after >3 hours of xenograft cold preservation time as well as long-term survival using FDA-approved immunosuppression. These data provide critical supporting evidence for the safety and feasibility of clinical kidney xenotransplantation. Moreover, long-term survival without CD40/CD154 costimulatory blockade may provide important insights for immunosuppression regimens to be considered for first-in-human clinical trials.

Funder

United Therapeutics Corporation

Publisher

Springer Science and Business Media LLC

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