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A genetically engineered pig's kidney has been removed from a transplanted patient after it began to lose its function, according to a statement from NU Langone Health on Friday. The patient, 54 years old Lisa Pisano of New Jersey, Her doctors said she was stable and on dialysis.
Pisano first received a mechanical heart pump, called an LVAD, on April 4, and then on April 12, he 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, Neu Langone said.
She had to be removed 47 days after the kidney transplant because of “unique challenges in managing her cardiovascular health and kidney function,” according to NYU Langone Health.
“There were several episodes where the blood pressure from her left ventricular assist device (LVAD) was not sufficient to provide adequate blood flow to her kidneys, causing a cumulative decline in her kidney function,” said Dr. Robert Montgomery, director of the website. NYU Langone Transplant Institute, in a statement. “On balance, the kidney is not contributing enough to sustain the immune system.”
According to Montgomery, after a recent kidney biopsy, there were no signs of rejection, but “there was significant damage to the kidney due to insufficient blood flow.”
Pisano's heart pump continues to work.
“Lisa is a pioneer and a hero in the quest to create a sustainable option for people awaiting organ transplants. Her strength and bravery in times of crisis inspire and motivate us as we continue to pursue the hope and promise of xenotransplantation,” said Montgomery.
The number of organs is much higher than the demand. Every day in America, 17 people die waiting for an organ, and kidneys are in short supply. According to the Organ Procurement and Transplantation Network, about 27,000 kidneys were transplanted by 2023, but about 89,000 people were on the waiting list for these organs.
Experts say that xenotransplants – transplanting animal organs into humans – are crucial to solving the shortage of organs. Gene editing makes precise edits to the pig's DNA to prevent the human body from recognizing and rejecting the animal's organs as foreign.
Pisano's doctors received approval from the US Food and Drug Administration for the new procedure under its broad access, or “compassionate use” policy, which gives patients at the end of the spectrum another option to access investigational treatment products outside of clinical trials.
The kidney came from a pig that had been genetically engineered to disrupt the gene responsible for sugar production called alpha-gal. It is found on animal cells and can be recognized and attacked by human antibodies. The role of the immune system is to help the thymus gland of the pig, which is located under the kidney membrane, to help the immune system recognize the organs of Pisano.
Although the kidney ultimately had to be removed from Pisano, Montgomery said the kidney will be studied for better understanding and the importance of her contribution to a greater goal.
“Lisa knows the world has a lot to learn from her legacy, and we will apply what she has taught us as we seek to make xenotransplantation a solution to an adequate supply of human organs,” Montgomery said in a statement.
's Catherine Dillinger contributed to this report.