(NEW YORK) — In a first-of-its-kind procedure, a terminally ill patient has become the first person in the world to undergo a gene-edited pig kidney transplant and also have a mechanical heart pump surgically implanted.
Surgeons at NYU Langone Health, in New York City, performed the operation in two steps, the first being the implantation of the heart pump. The second took place days later, with the transplant of a genetically modified pig kidney and the pig’s thymus gland — which makes white blood cells to help the immune system fight disease — to help prevent rejection.
The patient is 54-year-old Lisa Pisano, from New Jersey, who was facing heart failure and end-stage kidney disease, NYU Langone said Wednesday. Due to several chronic conditions, including being on dialysis, she was not a candidate for a heart transplant or a kidney transplant, the hospital said.
Additionally, Pisano has high levels of antibodies harmful to human tissue that would make it difficult to find a match for a human kidney transplant, according to the hospital. However, these antibodies were not harmful to gene-edited pig organs.
“All I want is the opportunity to have a better life,” Pisano said in a statement. “After I was ruled out for a human transplant, I learned I didn’t have a lot of time left. My doctors thought there may be a chance I could be approved to receive a gene-edited pig kidney, so I discussed it with my family and my husband.”
The NYU team says it believes this is the first documented case of a patient with a mechanical heart pump receiving an organ transplant of any kind. What’s more, this is just the second case of a gene-edited pig kidney transplanted into a living person, and the first with the thymus combined, according to the hospital.
The first case occurred last month when a surgical team at Massachusetts General Hospital connected the pig kidney’s blood vessels and ureter with those of 62-year-old Richard Slayman, a man living with end-stage kidney disease. The hospital has said he continues to recover well.
Pisano’s two procedures were performed by separate surgical teams about nine days apart. The first, on April 4, involved the surgical insertion of a device called a left ventricular assist device (LVAD), which helps pump blood from the lower left heart chamber to the rest of the body.
NYU Langone says it typically is used in patients who are waiting for a heart transplant or are ineligible to receive a transplant. The hospital added that Pisano would only have days or weeks to live without the LVAD.
Although end-stage kidney disease typically rules out patients from receiving an LVAD, the novel approach of using a gene-edited pig kidney helped get her approved for the procedure, according to doctors.
“Without the possibility of a kidney transplant, she would not have been eligible as a candidate for an LVAD due to the high mortality in patients on dialysis with heart pumps,” said Dr. Nader Moazami, chief of the division of heart and lung transplantation and mechanical circulatory support for the department of cardiothoracic surgery at NYU Grossman School of Medicine, who was one of the doctors who performed the LVAD surgery.
“This unique approach is the first time in the world that LVAD surgery has been done on a dialysis patient with a subsequent plan to transplant a kidney. The measure for success is a chance at a better quality of life and to give Lisa more time to spend with her family,” Moazami continued.
Doctors say the pig kidney has a single genetic modification, to “knock out” the gene that produces a sugar known as alpha-gal. Studies have shown that removing alpha-gal helps prevent rejection of xenotransplanted, or non-human, organs.
“By using pigs with a single genetic modification, we can better understand the role one key stable change in the genome can have in making xenotransplantation a viable alternative,” Dr. Robert Montgomery, who led the transplant surgery and is chair of the department of surgery and director of the NYU Langone Transplant Institute, said in a statement.
“Since these pigs can be bred and do not require cloning like more complex gene edits, this is a sustainable, scalable solution to the organ shortage. If we want to start saving more lives quickly, using fewer modifications and medications will be the answer,” Montgomery said.
Pisano’s two-step procedure required clearance by NYU Langone’s institutional review board and approval from the Food and Drug Administration under its “compassionate use” program, which often allows non-traditional methods to be used when a patient has a serious or life-threatening condition.
The xenotransplantation was performed on April 11 and Pisano continues to recover well, the hospital said.
Last year, researchers at NYU Langone Health in New York City conducted a two-month study of a genetically engineered pig kidney that had been transplanted into a 58-year-old man who had been declared brain-dead, with his family’s consent. The team observed only mild rejection that required intensifying immunosuppression medication to reverse it.
Experts have expressed hope that being able to transfer animal organs into human patients will help the future of the organ supply.
Currently, more than 103,000 men, women and children are on the national transplant waiting list, according to the Health Resources and Services Administration (HRSA), an agency of the Department of Health and Human Services. Each day, 17 people die waiting for a transplant and, every eight minutes, someone is added to the transplant list, according to the HRSA.
What’s more, many donor organs — including kidneys — are needlessly discarded every year, research shows. If these types of transplants for kidneys prove to work and be safe — this could one day make dialysis unnecessary for the more than 500,000 people in the United States who require it to live, according to the National Kidney Foundation.
“It is incredible to consider the scientific achievements that have led to our ability to save Lisa’s life, and what we are endeavoring to do as a society for everyone in need of a life-saving organ,” Montgomery said.
However, the edited animal organs bring up questions about if they will work long term, if they are safe and if it is ethical raising animals for human organ transplantation.
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