ScienceDaily: Heart xenotransplant protocols established for transplantation of organs from pigs to humans — ScienceDaily

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NYU Langone Health transplanted successfully two genetically engineered pig heart into recently deceased people in June, July. These accomplishments mark the latest steps towards addressing the nation’s organ shortage and creating a protocol that would allow for an alternative supply of organs to patients suffering from life-threatening heart diseases.

These procedures, also known as “xenotransplants”, were performed at NYU Langone’s Tisch Hospital on Thursday and Wednesday, June 16th, 2022. Nader Moazami MD, surgical director for heart transplantation at NYU Langone Transplant Institute, conducted the investigation using hearts from hundreds of miles away. These hearts were then transplanted into deceased donors who had been on ventilator support.

The heart transplants were done over several hours. Heart function was also monitored for three days. The first heart xenotransplant was completed on Sunday, June 19, 2022 and the second, on Saturday, July 9, 20,22. The hearts were healthy and functioning normally after the transplant. No evidence of porcine Cytomegalovirus (pCMV), was found in either case using a new infectious disease protocol. Extensive protocols were followed to monitor the potential for zoonotic porcine endogenous retrovirus transmission (PERV) and to prevent it from happening again. This study was conducted in an operating room that has been removed to allow future xenotransplantation research.

The hearts were obtained from pigs with 10 genetic modifications. These included 4 porcine gene knockouts to prevent rejection and abnormal growth, and 6 human transgenes (“knockins”) that promote the expression of important biologic pathways. Incompatibilities between humans and pigs can cause disruptions in these pathways. In this NYU Langone Health study, no other investigational devices nor medications were used. The current standards for heart transplantation have been applied to the procurement, transplant, surgery, and immunosuppression.

Dr. Moazami stated that the goal was to combine the best practices in an everyday heart transplant with non-human organs that can function normally without any additional medication or devices. “We are attempting to show that clinical trials can be carried out using this new supply of organs in conjunction with the proven transplant methods we have developed at the NYU Langone Transplant Institute.”

Alex Reyentovich MD, medical director for heart transplantation, and director of NYU Langone Advanced Heart Failure Program, stated that these new advances in xenotransplantation bring the field closer towards realizing a new supply organs for patients with life-threatening diseases.

“These are the first steps towards developing a deep understanding and practical application of standard clinical practice and tools for xenoheart transplantation,” stated Dr. Reyentovich.

Decedent Model Key for Xenotransplant Research

Robert Montgomery, MD. DPhil., is the H. Leon Pachter MD Professor and Chair of the Department of Surgery at NYU Grossman School of Medicine. He is also the director of NYU Langone Transplant Institute. Xenotransplant studies using recently deceased donors are crucial to gather additional human data to improve a field that, up until last year, was only tested with non-human primates.

He said, “Our greater purpose in life is to solve the organ shortage” and provide an alternative for the more 100,000 people waiting for that lifesaving gift. This work must be guided by the paradigm of whole-body donor, which is an option when organ donation is not possible. We are so grateful for the willingness of families to participate in this research that will save thousands more lives.

Dr. Moazami performed the surgeries as part of a larger study. The oversight board was specially appointed at NYU Langone. After consulting the New York State Department of Health, it was approved. This is the latest step of a protocol that requires similar procedures to be done. This new route allows an individual to fulfill their altruism after they have died. It is possible in cases where the organs or tissues of the deceased are not suitable for transplant.

Leonard Achan, RN MA, ANP, president of LiveOnNY, stated that “as the organ procurement organisation for the greater New York region we are supportive NYU Langone’s research efforts.” In normal circumstances, one donor can save as many as eight lives. Donor heroes in extraordinary cases can save lives by taking part in pioneering research. We are grateful to the families of these donor heroes for their willingness to help others. This research must be continued.

Protocol to Enhance Infectious Disease Prevention

Dr. Montgomery was the pioneer in xenotransplant surgery using single-gene knockout porcine kidneys in September 2021 and November 2021. He says that enhanced porcine virus monitoring is a critical element of this field’s success. This technology was used in the latest procedures.

“Other studies have indicated that pCMV may play a role in the success rate of xenotransplanted tissues,” he stated. To detect low levels of pCMV in donor pigs, more sensitive screening methods were developed. To ensure the organ’s long-term survival, we have added this additional screening to the heart transplant protocol.

Sapna Medha, MD, was the director for the NYU Langone Transplant Institute’s transplant infectious disease program.

These heart were obtained from pigs that Revivicor, Inc., a subsidiary United Therapeutics Corporation, provided funding.

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