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Pioneering Transplant Patient Stable and on Dialysis After Porcine Organ Removal Due to Unique Health Challenges

A genetically modified pig kidney has been removed from a transplant patient after it began to lose function, according to a statement released Friday by NYU Langone Health. The patient, 54-year-old Lisa Pisano from New Jersey, is stable and has started dialysis, her doctors have said.

Pisano initially received a mechanical heart pump, known as an LVAD, on April 4, followed by a kidney and thymus from a genetically modified pig on April 12. Her case marks the first reported organ transplantation in a person with a mechanical heart pump, NYU Langone stated, and it was the second known transplantation of a genetically modified pig kidney in a living recipient and the first transplanted with the thymus.

The kidney had to be removed due to “unique challenges in managing her cardiovascular health and renal function” 47 days after the transplant, NYU Langone Health reported.

There were several episodes where “the blood pressure she was able to generate from the left ventricular assist device (LVAD) was not adequate to provide optimal perfusion to the kidney, resulting in a cumulative reduction in its renal function,” said Dr. Robert Montgomery, director of the NYU Langone Transplant Institute, in the statement. “Overall, the kidney was no longer contributing sufficiently to justify continued immunosuppression regimen.”

There were no signs of rejection after a recent kidney biopsy, according to Montgomery, but there were “significant injuries to the kidney due to episodes of inadequate blood flow.”

Pisano’s heart pump continues to function.

“Lisa is a pioneer and a hero in the efforts to create a sustainable option for people awaiting organ transplants. Her strength and courage in the face of adversity inspire and motivate us as we continue to pursue the hope and promise of xenotransplantation,” Montgomery said.

The need for organs far exceeds the number available. Every day, 17 people die in the United States while waiting for an organ, with kidneys being the scarcest. Approximately 27,000 kidneys were transplanted in 2023, but nearly 89,000 people were on the waiting list for these organs, according to the Organ Procurement and Transplantation Network.

Experts argue that xenotransplantations – organ transplants from animals to humans – are crucial in addressing the organ shortage. Genetic editing makes precise modifications to a pig’s DNA to prevent the human body from recognizing the animal’s organs as foreign and rejecting them.

Pisano’s doctors received approval from the U.S. Food and Drug Administration to perform the new procedures under its expanded access or “compassionate use” policies, which give terminally ill patients with no other options access to experimental medical products outside of clinical trials.

The kidney came from a pig genetically modified to disrupt a gene responsible for producing a sugar called alpha-gal, found on the surface of animal cells and can be recognized and attacked by human antibodies. The pig’s thymus, which plays a role in immunity, was placed beneath the kidney in an attempt to help Pisano’s immune system recognize the organ.

While Pisano’s kidney ultimately had to be removed, Montgomery stated that the kidney would be studied for further insights and emphasized the importance of her contribution to the broader goal.

“Lisa knew that the world would learn a great deal from her altruism, and we will apply what she has taught us to make xenotransplantation a solution to the inadequate supply of human organs,” Montgomery said in the statement.

Katherine Dillinger from CNN contributed to this report.