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The first transplant surgery combining a mechanical heart pump and a gene-edited pig kidney has been completed at NYU Langone Health, the system announced Wednesday.
The subject was Lisa Pisano, a 54-year-old New Jersey resident who had heart failure and end-stage renal disease that required regular dialysis, according to a news release from New York University Langone. However, she was unable to undergo a standard heart or kidney transplant due to other chronic medical conditions that “significantly reduced the chance of a good outcome,” as well as a shortage of donor organs across the United States.
“When the opportunity first presented itself, I thought, 'I have to give it a try,'” Pisano said at a press conference Wednesday from his bed in the intensive care unit.
“I tried everything else, I exhausted all my other resources. So when this opportunity came up, I said, 'I'm going to take advantage of this,'” she said, adding, ” I wanted to spend time with my grandchildren and play with them.”
The need for organs far exceeds the number available. There is a kidney shortage in the United States, with 17 people dying every day waiting for donated organs. About 27,000 kidneys will be transplanted in 2023, but nearly 89,000 people are on the organ waiting list, according to the Organ Procurement and Transplant Network.
Experts say xenotransplantation, or transplanting animal organs into humans, is crucial to solving the organ shortage. Gene editing precisely edits a pig's DNA, preventing the human body from recognizing the animal's organs as foreign and rejecting them.
Pisano received a heart pump on April 4th, and a gene-edited pig kidney and pig thymus gland on April 12th. Her case is the first reported organ transplant to a person with a mechanical heart pump, and the first known transplant of a gene-edited pig kidney into a living recipient, according to New York University Langone. This is the second case, and the first to be transplanted together with the thymus gland.
Rik Suleiman, 62, the first survivor of a gene-edited pig kidney, received the organ at Massachusetts General Hospital in March and was able to go home this month. Pig hearts were also transplanted into two survivors who died within weeks of receiving their organs.
In a video provided by New York University Langone, she said that in addition to kidney disease, Pisano has congestive heart failure and has had a stent placed in her heart and multiple catheterizations. . In 2020, she learned she had colon cancer and had “a large portion” of her colon removed, her husband Todd said in a video from NYU Langone.
Dr. Robert Montgomery, director of the New York University Langone Transplant Institute, which led the operation, said in a video from NYU Langone that Pisano's condition was “deteriorating, and in fact, she may only have days to live. “It may be measured in a few weeks.” At a press conference Wednesday, he described her situation as a “medical 'Catch-22.'” ”
“Although she had both heart failure and kidney failure, she was not a candidate for a combined heart and kidney transplant given her other health conditions,” Montgomery said.
Her doctors received permission from the U.S. Food and Drug Administration to perform the new procedure under expanded access or “compassionate use” policies, which give terminally ill patients with no other options access to investigational drugs outside of clinical trials. I got it.
The kidneys come from pigs that have been genetically engineered to disrupt a gene responsible for producing a sugar called alpha-gal on the surface of animal cells, which is recognized and attacked by human antibodies. The pig's thymus gland, which plays a role in immunity, was placed under the cover of a kidney to help Pisano's immune system recognize the organ.
Professor Montgomery pointed out that the gene editing used in the pigs was much simpler than that used in other xenotransplants into living humans. “We will have an opportunity to really address the problem we are trying to tackle, which is organ scarcity. The more complex the gene edits, the less likely it is that we will be able to reproduce.” Add to. All pigs must be cloned organ by organ. It's not something that can be easily scaled up. …So in this case, less feels like more. ”
Pisano has “a long way to go,” but “her kidneys are working wonderfully. … Her heart condition is much better.” Now doctors are focusing on: Problems such as rejection or infection. They expect she will need at least another month of rehabilitation before being released from the hospital.
Pisano said that before the surgery, she had significant problems just walking. “She couldn't sit up and breathe. She couldn't do anything,” she said. Now, she says, “I feel the best I've felt in a while,” and she's optimistic about the outcome.
“The worst-case scenario is, if it doesn't work, it might work for the next person,” she says. “At least someone will benefit from it.”
CNN's Nadia Kounan, Jen Christensen and Jacqueline Howard contributed to this report.
