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Dr. Jeffrey Stern, assistant professor of surgery at New York University's Grossman School of Medicine, and Dr. Robert Montgomery, director of the New York University Langone Transplant Institute, prepare a gene-edited pig kidney with a thymus for transplantation.
Joe Carotta, NYU Langone Health
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Joe Carotta, NYU Langone Health
Dr. Jeffrey Stern, assistant professor of surgery at New York University's Grossman School of Medicine, and Dr. Robert Montgomery, director of the New York University Langone Transplant Institute, prepare a gene-edited pig kidney with a thymus for transplantation.
Joe Carotta, NYU Langone Health
NEW YORK — Lisa Pisano lay in a hospital bed at New York University Langone Health, connected to beeping monitors and a series of tubes. Her surgery wound was still healing and she looked tired. But the 54-year-old New Jersey woman said she hasn't felt this good in years.
“I'm feeling better and better every day,” said Pisano, 54, of Cookstown, New Jersey. “I got a piece of myself back. I'm not there yet, but I'm getting closer.”
Ten days ago, Pisano became the second survivor in the world to have a genetically modified pig kidney transplanted into his body to replace his own kidney. We're screwed Doctors announced Wednesday that his organs were damaged. A Massachusetts man harvested his first pig kidney last month.
Pisano also obtained a thymus gland from the same genetically engineered pig to prevent the body from rejecting the kidney, and a pump to strengthen the failing heart.
Two days before her kidney transplant was publicly announced, Pisano said in a bedside interview that she was “surprised.” “I’m really surprised that that’s an option for me, because I never thought I would have that option.”
Advances in animal organ transplantation into humans
Pisano's transplant is the latest development in a fast-paced effort to use genetically modified pigs to solve the persistent shortage of organs for transplant. More than 103,000 people are currently on the organ donation waiting list.about 17 people die every day Because they can't have it.
“We are in a new world in transplantation,” he said. robert montgomery, which runs New York University's Langone Transplant Institute, where the surgery took place. “This will be a sustainable and unlimited source of organs. This will be transformative.”
Many transplant experts are excited about this study. However, this approach also raises some concerns. Some doctors are concerned that pig organs could spread the virus to humans. Some critics are uncomfortable with the prospect of raising thousands of genetically modified animals to be slaughtered for their organs. Some worry about using vulnerable patients for experiments.
“This is truly a breakthrough procedure,” he said. Karen Maschkea bioethicist at the Hastings Center, a bioethics think tank in Garrison, New York. “But there are many issues that need to be discussed.”
Montgomery said that when Pisano arrived at the hospital, she was expected to die within weeks, possibly days. Years of diabetes had taken a terrible toll. She had multiple heart attacks and was on dialysis to replace her failing kidneys.
“I really didn't have a life,” she said. “I didn't do anything. I just sat there. I couldn't get up and do anything. I couldn't even make dinner. I couldn't vacuum. I couldn't vacuum. I couldn't play with my grandchildren because I couldn't do it.'' I couldn't do anything for them. It was a really, really heartbreaking feeling. It was really bad. ”
Pisano had too many other health problems, particularly serious heart problems, to qualify for a human organ transplant. So she jumped at the chance to get her hands on a pig's kidney.
“My first thought was, 'Wow, I can't believe that was possible.' So when it came to my attention, I thought, 'You know what? 'I'll try it.' I said, 'You know what I'll do? I have to do it for myself and the rest of my family.'
Transplant for research — and to buy time
The hope is that the pig kidney will give Pisano at least a little more time and provide researchers with important information that can be used to improve the outcomes of future transplants. Pisano also needs to take anti-rejection medication.
“When we took her to the hospital, she was in very bad condition,” Montgomery said. “No one could have imagined it would go so smoothly.”
“Her kidneys are working better than yours or mine, so I'm optimistic that she'll be able to go home and be with her children and grandchildren and live a comfortable life,” Montgomery said. he told NPR in an interview before the announcement.
But he stressed that it would probably take several months of recovery in the hospital before she could go home. He also said he could not predict how much more time Pisano would gain from the surgery.
Beyond Pisano's case, much more research is needed before genetically modified pig organs can be used commonly. “It's still too early,” Montgomery said. “It's still early days. There's still a lot we need to learn and perfect.”
Surgeons have previously transplanted kidneys and livers from genetically engineered cloned pigs into baboons whose brains have stopped functioning and into a small number of people. Surgeons at the University of Maryland even performed heart tests on two men who had no other options. They survived several weeks after the procedure. A Massachusetts man who suffered from pig kidney disease was released from the hospital within weeks and is doing well, according to Massachusetts General Hospital.
Pig organs are genetically modified for compatibility with humans
The organs come from pigs that have been genetically modified to minimize the risk of human rejection, spreading the swine virus to humans, or causing other complications. be.
NPR recently had exclusive access to one research farm that raises pigs. Rivi Victor Blacksburg, Va., the biotechnology company that manufactured the kidneys and thymus glands Pisano received. The kidney transplanted in Boston egenesis Born in Cambridge, Massachusetts.
The companies hope that one day there will be enough genetically modified pigs in supply to save thousands of lives.
Modified organs have not been reviewed or approved for widespread use.
Pig heart and kidney transplants were made possible by the Food and Drug Administration as part of the “.considerate useA program aimed at helping desperate patients.
“I think there are concerns about doing experiments in this way that finds the most desperate patients who have no other options,” he said. L. Sid Johnsona bioethicist at Upstate Medical University of New York in Syracuse, New York.
“Maybe those patients will benefit. Maybe they believe they will benefit and the risk is worth it to them. But if we do these experiments… “I am concerned that in doing so, we are taking advantage of particularly vulnerable and desperate patients,” Johnson said.
Some doctors who perform the transplants and independent observers say volunteers are fully informed about the risks and potential benefits.
But some want the FDA to approve a formal study to fully evaluate the approach, rather than granting approval for individual patients.
“This is an amazing development. It's happening at an incredible speed.” michael gasmano, a bioethicist at Lehigh University. “However, we remain concerned about using expanded access protocols instead of proceeding with the trial.”
The companies expect the FDA to approve a formal study soon.
Pisano hopes to spend a little more time with his grandchildren.
“Anytime on this planet, it’s better than nothing,” she said. “So if I'm given two years, that's two years I've never had before.”
