Successful heart xenotransplant experiments set protocol for pig-to-human organ transplantation

A team at NYU Langone Health successfully transplanted two genetically engineered pig hearts into recently deceased humans in June and July, marking the latest advances toward addressing the nationwide organ shortage and developing a clinical protocol that would provide an alternative supply of organs for people with life-threatening heart disease.

The surgeries, known as xenotransplants, were performed on Thursday, June 16, 2022, and Wednesday, July 6, 2022, at NYU Langone’s Tisch Hospital. Nader Moazami, MD, surgical director of heart transplantation at the NYU Langone Transplant Institute, led the investigational procedures using hearts procured from a facility hundreds of miles away and transplanted into recently deceased donors maintained on ventilator support.

The transplant surgeries were performed over several hours and heart function was monitored for three days. The first heart xenotransplant concluded on Sunday, June 19, 2022, and the second on Saturday, July 9, 2022. No signs of early rejection were observed in either organ and the hearts functioned normally with standard post-transplant medications and without additional mechanical support. Using a new infectious disease protocol, no presence of porcine cytomegalovirus (pCMV) was detected in either case. Strict protocols to prevent and monitor potential zoonotic transmission of porcine endogenous retrovirus (PERV) were also carried out. The operating room used for this study has been taken offline to be used only for future xenotransplantation research.

The hearts were procured from pigs that had 10 genetic modifications, including 4 porcine gene “knockouts” to prevent rejection and abnormal organ growth as well as 6 human transgenes (“knock-ins”) to promote expression of proteins that regulate important biologic pathways that can be disrupted by incompatibilities between pigs and humans. No other investigational devices or medications were used in this NYU Langone Health study. The procurement, transport, transplant surgery, and immunosuppression were aligned with current clinical standards used in heart transplantation.

“Our goal is to integrate the practices used in a typical, everyday heart transplant, only with a nonhuman organ that will function normally without additional aid from untested devices or medicines,” said Dr. Moazami. “We seek to confirm that clinical trials can move ahead using this new supply of organs with the tried-and-true transplant practices we have perfected at the NYU Langone Transplant Institute.”

Alex Reyentovich, MD, medical director of heart transplantation and director of the NYU Langone Advanced Heart Failure program, said these latest advances in xenotransplantation move the field closer to realizing a new supply of organs for those facing life-threatening disease.

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