The US Food and Drug Administration (FDA) is understood to be drawing up plans to make it easier for researchers to study larger numbers of patients. So far, there are only a few single xenograft transplants, which are considered a possible solution to the shortage of human donors. There was excitement earlier this year when a 57-year-old ex-convict from Maryland became the first person in the world to successfully live with a pig’s heart in January. David Bennett, who was terminally ill, died two months later, but his death is believed to have been due to the infection of the pig’s heart rather than the failure of the operation. The fact that his body did not immediately reject the organ was considered a major breakthrough and is raising hopes that it can be done safely on a larger scale. Clinical trials allow for the study of larger numbers of patients, robust data collection, and rigorous safety monitoring. U.S. approval could come as early as next year, sources told the Wall Street Journal. British experts previously predicted that pig hearts could be used in the NHS within the next decade. Ex-convict David Bennett (pictured watching Super Bowel after surgery), 57, of Hagerstown, Maryland, died March 8 — two months after he was given a pig heart in the world’s first animal-to-human organ transplant A pig heart was collected for a patient with end-stage heart disease who was not suitable for a human heart transplant. The scientists inserted six human genes into the donor pig’s genome – modifications designed to make the organ more tolerable to the human immune system. They turned off four genes, including the sugar in his cells responsible for this ultra-rapid organ rejection and a growth gene to prevent the pig’s heart, which weighs about 267 grams compared to the average human heart weighing 303, from continuing to expand. grams. Surgeons at the University of Maryland Medical Center performed a nine-hour operation to remove the patient’s heart and insert the damaged pig heart Surgeons at the University of Alabama at Birmingham have already approached the FDA about a potential trial. Transplant surgeon Dr. Robert Montgomery, of New York University, also confirmed that his lab is looking to do trial operations next year.

Man who donated pig heart ‘may have died because organ was infected’

An ex-convict who received a pig’s heart in a world-first transplant may have died because the organ was infected by a virus, experts claim. David Bennett, 57, from Maryland, US, died on March 8 — two months after receiving the heart from the genetically modified animal. Doctors at the Maryland Medical Center, where the surgery was performed, said “no apparent cause was identified at the time of his death.” But the lead surgeon behind the forensic act, Dr Bartley Griffith, now hints that the heart may have been infected by porcine cytomegalovirus. Dr. Griffiths said in an April 20 webinar that his team was “beginning to learn why [Mr Bennett] passed,” according to the MIT Technology Review. The surgeon is said to have added the virus “maybe it was the actor, or it could be the actor, that started this whole thing.” Now questions are being raised about Revivicor, the biotech company that bred and manufactured the pigs. Revivicor declined to comment to MIT Technology Review and has not made a public statement about the allegations. And the team at the University of Maryland Medical Center in Baltimore, which operated on Mr. Bennett, is also in talks to conduct a trial. Scientists have been toying with animal-to-human organ donation for centuries, dating back to the 1800s when wounds were treated with skin grafts from frogs. The use of pig heart valves is already commonplace now, but whole organ transplantation has proved too risky until recently. If scientists can crack whole-animal organ transplants, it could save thousands of lives every year. In the US, 20 people die every day waiting for an organ donor, on average, while in the UK around one Briton dies a day. But the problem has become a global phenomenon as the world’s population ages and there is greater demand and fewer dead donors. Speaking to an FDA advisory panel on Wednesday, Dr. Montgomery said, “We are on the road to clinical trials.” Clinical trials offer a safer way for researchers to test new drugs than emergency procedures because they require scientists to do rigorous checks beforehand. They have three phases, which minimize risk when it comes to eventually scaling up efforts. Trials must also be approved by an FDA ethics committee before they begin. The pig used in Mr Bennett’s transplant had been genetically modified to remove several genes that would have led to his body rejecting the organ. This involved removing a certain sugar in the cells that is known to cause rapid rejection. Rejection is caused by the immune system recognizing the graft as a foreign object, triggering a response that will eventually destroy the transplanted organ or tissue. About 50 percent of all transplanted human organs are rejected within 10 to 12 years, by comparison. Doctors at the Maryland Medical Center are investigating whether porcine cytomegalovirus is behind Mr Bennett’s death. The infection was confirmed in an article published in the New England Journal of Medicine. The heart was found to harbor the virus 20 days after the surgery, they said, despite the fact that the pigs that bred it were supposed to be screened for infection before the transplant. Dr. Griffiths, the lead surgeon on the operation, said in an April 20 webinar that the virus “may have been the actor or could be the actor that triggered this whole thing.” The FDA allowed Maryland’s earlier experiment under “palliative use” rules for emergency situations. Mr Bennett was not suitable for a human heart or pump because he had end-stage heart failure. He also failed to follow his doctors’ orders, missed appointments and stopped taking prescribed medications. Doctors at the Maryland Medical Center, where the surgery took place, did not give an exact cause of death at the time Years before the operation, Mr Bennett was sentenced to 10 years in prison for stabbing Edward Shumaker, then 22, seven times in the back while playing pool in 1988. The victim was paralyzed by the waste and died in 2007. Mr Bennett is believed to have served only half of his prison sentence. Dr. Allan Kirk, a transplant surgeon at Duke University School of Medicine, told the FDA committee that existing technology could test hearts for swine viruses. He said this would be easier to do in clinical trials, ensuring patients did not suffer the same fate as Mr Bennett. Since then, the Maryland researchers have been asked by the FDA to begin testing pig transplants on baboons before moving on to human trials. Professor Muhammad Mohiuddin, one of the surgeons who operated on Mr Bennett, said the team was currently continuing animal testing. They are also asking the FDA what steps will be necessary before starting human clinical trials. In 2020, German researchers found that pig hearts transplanted into baboons lasted only a few weeks if the heart was infected with the same virus found in Mr Bennett. In comparison, organs that were free of viruses survived more than six months. These researchers found “surprisingly high” levels of virus in the organ when they autopsied the monkeys. Some believe that the virus breaks out because it is in a foreign immune system that does not recognize or fight it. The virus found in Mr Bennett’s donor heart is not believed to be capable of infecting human cells. However, the pathogen is capable of damaging the pig’s heart, which may have damaged the organ and contributed to its death.

How was the world’s first pig heart transplant surgery possible?

David Bennett, a 57-year-old handyman from Baltimore, Maryland, was the first person in the world to receive a pig heart transplant. The operation was carried out as Mr Bennett did not meet the criteria for a human heart transplant and faced death from heart disease if he did not undergo the operation. “It was die or do this transplant,” he said. He died on March 9, although doctors did not reveal a cause of death Have animal organs been transplanted into humans before? Scientists have been toying with animal-to-human organ donation, known as xenotransplantation, for decades.
Skin grafts were performed in the 1800s from a variety of animals to treat wounds, with frogs being the most popular. In the 1960s, 13 patients were given chimpanzee kidneys, one of whom returned to work for nearly 9 months before suddenly dying. The rest died within weeks. At that time there were no human organ transplants available and chronic hemodialysis was not yet in use. In 1983, doctors at Loma Linda University Medical Center in California transplanted a baboon heart into a premature baby born with a fatal heart defect. Baby Fae lived just 21 days. The case was controversial months later when it was revealed that the surgeons did not attempt to obtain a human heart. More recently, waiting lists for transplants from deceased or allogeneic donors are increasing as life expectancy increases worldwide and demand increases. In October 2021, surgeons at NYU Langone Health in New York successfully transplanted a pig kidney into a human for the first time. It started working as it should, filtering out waste and producing urine without causing rejection by the recipient’s immune system. The recipient was a brain-dead patient in New York with signs of kidney failure whose family agreed to the experiment before being taken off life support. Why wouldn’t his body reject the animal organ? Previous attempts to insert animal organs into human hearts have largely failed because the patients’ bodies quickly rejected them. Rejection…