more than six million Americans have heart failure, and about 100,000 of these people have end-stage heart failure.Many of these people die while waiting for heart transplant due to lack of organ donors – US Surgeon General implement There were only about 3,800 heart transplants last year.
NYU Langone Groundbreaking research is underway to address the organ defects that cause so many patients to die while waiting for human heart transplants.In the past 30 days, New York City’s health system successful transplant Two genetically modified pig hearts were implanted in deceased people who donated their bodies to medical research.
Cardiac xenotransplantation, the transplant of an organ from one species to another, has only been performed 3 times in human subjects—two recent experimental procedures at NYU Langone and the case of David Bennett. In January, Bennett became the first person in the world to receive a genetically modified pig heart following Dr. Bartley Griffith’s transplant at the State University of New York. University of Maryland Medical Center.
Bennet passed away two months after surgery. Dr. Robert Montgomery, director of NYU’s Langone Transplant Institute, said the genetically modified pig heart that kept him alive for two months remains a “remarkable feat.”He says The medical community is still trying to understand why the heart failed and why Bennett died.
Dr. Montgomery told a media conference on Tuesday that Bennett’s death showed that there is still much to be learned and explored in the medical field when it comes to human xenotransplantation — which is best studied with deceased patients.
The most recent experimental procedure at NYU was led by Dr. Nader Moazami, director of the Transplant Institute’s Cardiac Transplant Surgery. The two pig hearts used for these xenografts had 10 individual genetic modifications. Most of the modifications were related to avoiding rejection of another species’ organs, one of which was to ensure the heart didn’t overgrow and fit into the human ribcage.
The procedures were performed on two patients declared brain dead, who had previously agreed to keep their bodies alive for medical research.surgery is It was performed for several hours, and heart function was monitored for three days after surgery. There were no signs of early rejection in either organ. Both transplanted hearts functioned normally with standard post-transplant medications and without mechanical support.
These xenografts allowed the NYU Langone research team to understand how the human body responds to the pig heart—an understanding not available from previous studies involving primates. The team was able to see how the body was able to maintain its bodily functions and blood flow, and also made the exciting discovery that these procedures could be performed without the help of an irrigation pump.
Irrigation pumps help patients flow blood through body tissues during heart surgery. In previous studies involving porcine heart xenotransplantation into primates, the use of a perfusion pump during surgery was critical for maintaining cardiac function.
Finding answers to questions such as whether a human heart xenotransplantation requires a pump is why experimental studies in deceased humans are so important, Dr. Montgomery said. He noted that perfusion pumps are difficult to use and expensive. If human heart xenotransplants do not require pumps, this would greatly increase the number of transplant centers that can participate in these life-saving procedures.
While the preliminary data his team shared was exciting, Dr. Moazami was careful to point out that both studies lasted only 72 hours. The researchers don’t know how long the human body can maintain a pig’s heart over time.
“There are still many questions that need to be answered before a Phase 1 trial, including what kind of patients are suitable for this trial,” he said. “So I think we’re looking at these results with cautious optimism.”
NYU Langone is planning to conduct a similar study on the deceased so they can gather as much data as possible before starting the Phase 1 trial. Generous donors are hard-earned, so the system is waiting for more patients to donate their bodies to science. As for when a phase 1 trial might be possible, Dr. Montgomery said it was hard to say, but it could be by 2025.
“It’s a bit like asking ‘how long is a rope?'” he said. It’s really hard to know because FDA clearance is required to start such trials, and we still don’t fully know what level of evidence is required to start a phase 1 trial. Our strategy is to continue trying to learn as much as possible so that we can conduct these trials fully informed. “
While there is still a lot of research to be done, Dr. Montgomery said his team is encouraged by their recent findings and excited to continue studying xenotransplantation in humans. Medical researchers are now one step closer to creating a “renewable, sustainable source of organs,” he said.
Image: Natali_Mis, Getty Images
