A genetically engineered pig kidney has been removed from a transplant patient after it started losing function, according to a statement on Friday from NYU Langone Health. The patient, 54-year-old Lisa Pisano of New Jersey, is stable and has started dialysis, her doctors said.
Pisano first received a mechanical heart pump, called an LVAD, on April 4 and then, on April 12, received a kidney and thymus gland from a gene-edited pig. Her case is the first reported organ transplant in a person with a mechanical heart pump, NYU Langone said, and it was the second known transplant of a gene-edited pig kidney into a living recipient and the first transplanted along with the thymus.
The kidney had to be removed due “unique challenges in managing both her cardiovascular health and kidney function” 47 days after the transplant, NYU Langone Health said.
There were multiple episodes where “the blood pressure she could generate from the left ventricular assist device (LVAD) was not adequate to provide optimal perfusion to the kidney, causing cumulative reduction in her kidney function,” said Dr. Robert Montgomery, director of the NYU Langone Transplant Institute, in the statement. “On balance, the kidney was no longer contributing enough to justify continuing the immunosuppression regimen.”
There were no signs of rejection after a recent biopsy of the kidney, according to Montgomery, but there was “significant injury to the kidney from episodes of insufficient blood flow.”
Pisano’s heart pump is continuing to function.
“Lisa is a pioneer and a hero in the effort to create a sustainable option for people waiting for an organ transplant. Her strength and bravery in the face of adversity inspires and drives us as we continue pursuing the hope and promise of xenotransplantation,” said Montgomery.
The need for organs far outstrips the number available. Every day, 17 people die in the US waiting for an organ, and kidneys are in shortest supply. According to the Organ Procurement and Transplantation Network, roughly 27,000 kidneys were transplanted in 2023, but nearly 89,000 people were on the waiting list for those organs.
Experts say xenotransplants – transplants of animal organs into people – are crucial to solving the organ shortage. Gene editing makes precise edits to a pig’s DNA to help keep the human body from recognizing the animal’s organs as foreign and rejecting them.
Pisano’s doctors received permission from the US Food and Drug Administration to do the new procedures under its expanded-access or “compassionate use” policies, which give terminally ill patients without other options access to investigational medical products outside of clinical trials.
The kidney came from a pig genetically engineered to disrupt a gene responsible for the production of a sugar, called alpha-gal. It’s found on the surface of animal cells and can be recognized and attacked by human antibodies. The pig’s thymus gland, which plays a role in immunity, was placed under the cover of the kidney in an attempt to help Pisano’s immune system recognize the organ.
While the kidney ultimately had to be removed from Pisano, Montgomery said the kidney would be studied for further insights and stressed the importance of her contribution to the larger goal.
“Lisa knew the world would learn a great deal through her altruism, and we will apply what she has taught us as we seek to make xenotransplantation a solution for the inadequate supply of human organs,” Montgomery said in the statement.
