The first investigational transplant of a genetically engineered, nonhuman kidney to a human body was recently completed at NYU Langone Health—marking a major step forward in potentially utilizing an alternative supply of organs for people facing life-threatening disease.
Known as xenotransplantation, the surgery was performed on Saturday, September 25, 2021, at NYU Langone’s Kimmel Pavilion. Robert Montgomery, MD, DPhil, the H. Leon Pachter, MD, Professor of Surgery and chair of the Department of Surgery at NYU Langone and director of the NYU Langone Transplant Institute, led a surgical team during the two-hour operation. The kidney was obtained from a genetically engineered pig hundreds of miles away and transplanted into a deceased donor. The donor was maintained on a ventilator, with the consent of the family, for 54 hours while doctors studied the kidney’s function and watched for signs of rejection.
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. Additionally, the pig’s thymus gland, which is responsible for “educating” the immune system, was transplanted with the kidney to stave off novel immune responses to the pig kidney.
The surgery was part of a larger study approved by a specially designated research ethics oversight board at NYU Langone. It is the latest step in a research protocol that calls for additional and similar procedures to be performed. Whole body donation after death for the purpose of breakthrough studies represents a new pathway that allows an individual’s altruism to be realized after brain death declaration in circumstances in which their organs or tissues are not suitable for transplant.
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 the 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 from a human kidney transplant. Throughout the procedure and subsequent observation period, no signs of rejection were detected. The results of the study will be presented for peer review and subsequent publication.
The number of usable, donated organs available for transplant has not grown sufficiently over the past half century, while the need for organs has soared. According to data compiled by the Organ Procurement and Transplantation Network of the U.S. Department of Health and Human Services, there are more than 90,000 people awaiting a lifesaving kidney transplant in the United States ,and more than 32,000 people have been added to the national kidney waitlist year to date.