NYU Langone Health performs second successful investigational xenotransplantation procedure

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 of Surgery and chair of the Department of Surgery at NYU Grossman School of Medicine 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. There is much more work to do before we begin living human trials, but our preliminary findings give us hope."

Robert Montgomery, MD, DPhil, Director, NYU Langone Transplant Institute

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 GalSafe^TM 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 Dr. 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.