CNN
—
NYU Langone Health announced on Friday that a genetically modified pig kidney had been removed from a transplant patient, 54-year-old Lisa Pisano of New Jersey, after it began to fail. Doctors said his condition was stable and he had begun dialysis.
Pisano was first fitted with a mechanical heart pump, known as an LVAD, on April 4, and then received a gene-edited pig kidney and thymus transplant on April 12. According to NYU Langone, hers is the first reported organ transplant into a person with a mechanical heart pump, the second live donor transplant of a gene-edited pig kidney, and the first to be transplanted with a thymus.
The kidney had to be removed 47 days after transplant due to “the unique challenges of managing both cardiovascular health and renal function,” New York University Langone Medical Center said in a statement.
Dr. Robert Montgomery, director of the New York University Langone Transplant Institute, said in a statement that there were multiple episodes in which the blood pressure generated by the LVAD was insufficient to provide optimal perfusion to the kidneys, leading to a cumulative decline in kidney function. “Taken together, the kidneys were no longer functioning sufficiently to justify continued immunosuppressive therapy.”
Montgomery said a recent kidney biopsy showed no signs of rejection, but “there was significant damage to the kidney due to a lack of blood flow.”
Pisano's heart pump continues to function.
“Lisa is a pioneer and a hero in the effort to create sustainable options for people waiting for organ transplants. Her strength and courage in the face of adversity inspires and motivates us as we continue to pursue the hope and possibilities of xenotransplantation,” Montgomery said.
Demand for organs far outstrips supply: 17 people die every day in the United States waiting for an organ, with kidneys the most in short supply. According to the Organ Procurement and Transplant Network, about 27,000 kidneys will be transplanted in 2023, but there are about 89,000 people on the waiting list for organs.
Experts say xenotransplantation – the transplantation of animal organs into humans – is essential to solving the organ shortage, using gene editing to precisely edit pig DNA to stop the human body recognising the animal organs as foreign and rejecting them.
Pisano and his doctors received permission from the Food and Drug Administration to perform the new procedure under the expanded access, or “compassionate use,” policy, which allows terminally ill patients with no other options to access investigational drugs outside of clinical trials.
The kidney came from a pig that had been genetically engineered to destroy the gene responsible for the production of a sugar called alpha-gal, which sits on the surface of animal cells and is recognized and attacked by human antibodies. The pig's thymus, which plays an important role in immunity, was hidden underneath the kidney so that Pisano's immune system could recognize the organ.
Although Pisano's kidney ultimately had to be removed, Montgomery said it would be studied to learn more, and emphasized the importance of her contribution to the larger goal.
“Lisa knew the world had much to learn through her altruism, and we will apply what she taught us as we explore xenotransplantation as a solution to the human organ shortage,” Montgomery said in a statement.
CNN's Katherine Dillinger contributed to this report.
