Health

Successful Xenotransplantation Surgery: Genetically Engineered Pig Kidney Transplanted to Human Body

Less than two months after the first breakthrough surgery, NYU Langone Health has performed its second successful investigational xenotransplantation procedure using a genetically engineered pig kidney. This second surgery is a sign of continued progress toward a potential alternative supply of life-saving organs.

Leading the second surgical procedure was Robert Montgomery, MD, DPhil, the H. Leon Pachter, MD, Professor and chair of the Department of Surgery at NYU Langone and director of the NYU Langone Transplant Institute. He transplanted a pig kidney lacking the alpha-gal gene to a recently deceased donor maintained on a ventilator. LiveOnNY, the nonprofit organization that facilitates organ and tissue donation in the greater New York City area, assisted in identifying a generous whole-body donor to help move this landmark research forward.

“We have been able to replicate the results from the first transformative procedure to demonstrate the continued promise that these genetically engineered organs could be a renewable source of organs to the many people around the world awaiting a life-saving gift,” says Montgomery. “There is much more work to do before we begin living human trials, but our preliminary findings give us hope.”A genetically engineered pig kidney is cleaned and prepared for transplantation to a human. Credit: Joe Carrotta / NYU Langone HealthDr. Robert Montgomery, the H. Leon Pachter, MD, Professor and chair of the Department of Surgery at NYU Langone and director of its Transplant Institute, prepares sutures for use in the xenotransplantation surgery. Credit: Joe Carrotta / NYU Langone Health
Dr. Robert Montgomery, the H. Leon Pachter, MD, Professor and chair of the Department of Surgery at NYU Langone and director of its Transplant Institute, performs the first xenotransplantation of a genetically engineered nonhuman kidney to a human at NYU Langone Health. Credit: Joe Carrotta / NYU Langone HealthThe surgical team at NYU Langone Health examines the porcine kidney for any signs of hyperacute rejection. The organ was implanted outside the body to allow for observation and tissue sampling during the 54-hour study period. Credit: Joe Carrotta / NYU Langone Health
The porcine kidney appears healthy and following perfusion and the ureter is prepared to allow for urine production. Credit: Joe Carrotta / NYU Langone HealthThe porcine kidney appears healthy and following perfusion and the ureter is prepared to allow for urine production. Credit: Joe Carrotta / NYU Langone Health

The procedure, part of an ongoing study, was performed on Monday, November 22, 2021, at an NYU Langone research laboratory in Manhattan. The kidney was procured from a GalSafeTM pig engineered by Revivicor, Inc., a subsidiary of United Therapeutics Corporation. The gene that encodes the glycan known as alpha-gal—which is responsible for a rapid antibody-mediated rejection of porcine organs by humans—was “knocked out” in the donor pig. The pig’s thymus gland, responsible for “educating” the immune system, was fused with the kidney before transplantation.

The kidney was attached to the blood vessels in the upper leg, outside the abdomen, and covered with a protective shield for observation and kidney tissue sampling over a 54-hour period of study. Urine production and creatinine levels—key indicators of a properly functioning kidney—were normal and equivalent to what is seen in a human kidney transplant. Throughout the procedure and subsequent observation period, there were no signs of rejection.

“We continue to make progress with the single-gene knockout xenotransplantation,” says Montgomery. “With additional study and replication, this could be the path forward to saving many thousands of lives each year.”

There are currently more than 90,000 people in the United States awaiting a life-saving kidney transplant, according to the United Network for Organ Sharing.

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