Tuesday, February 4, 2025 (Healthday News) – The US Food and Drug Administration (FDA) took a major step in interspecies transplantation by testing pig kidney transplants in its first clinical trial in patients with renal failure.
Two biotechnology companies, United Therapeutics Corporation and EgnesisIt was cleared to start their research this year.
If successful, these tests will revolutionize organ transplantation and help address serious shortages in donor kidneys.
“We are entering a transformational era in organ transplantation.” Mike Curtissaid Egenesis's president and CEO. New York Times.
United Therapeutics Corporation will begin research with six patients. All have been on dialysis for at least six months and there are no other serious medical issues. Once the initial transplant works out, it will eventually expand to 50 participants. Egnesis starts with three patients and increases in stages.
Doctors monitor each transplant patient for 24 weeks and require lifelong follow-up to track health outcomes and potential risks, such as pathogens that can range from pigs to humans. The era.
More than 550,000 Americans suffer from kidney failure, and nearly 100,000 people are on the transplant waiting list. However, in 2023, fewer than 25,000 kidney transplants occur, with many patients waiting for years or death before receiving the donor organ. The era.
GMO pigs offer a promising solution because organ size and function are similar to human kidneys.
Both companies have changed pig genes to reduce the risk of organ rejection and improve compatibility with the human body.
United Therapeutics Pigs undergoes 10 gene editing, adding six human genes and removing four pig genes associated with rejection.
Egenesis Pigs undergoes 69 gene editing, mostly because they inactivate viruses that can pose a risk to humans.
The potential benefits of xenotransplants are groundbreaking, but safety and ethical concerns persist.
While some experts are concerned about known pathogens that jump from pig to human, both companies are raising pigs in pathogen-free facilities that adhere to strict biosecurity protocols and regularly screen for pathogen animals. The era It has been reported.
Christopher BobierAssociate Professor specializing in bioethics and health policy at the University of Central Michigan School of Medicine, spoke. The era In the worst case scenario, animal organ recipients can “infect undetected pathogens from pig sources.”
Others question whether patients can really give consent given how difficult it is for people on dialysis to reject potential life-saving solutions.
“It would be incredibly difficult to say no,” Bovier said. “It will be even more difficult to fully grasp the meaning of that decision's life.”
United Therapeutics expects to begin transplants by mid-2025, and will take several months between the steps to assess each outcome before moving forward.
Egenesis will wait six months between the first two patients, then three months in advance.
Even if these trials are successful, it remains unclear whether pig organ transplant costs and insurance will cover them. The era.
More information
Mayo Clinic has more Kidney Transplantation.
sauce: New York TimesMedia Report, February 3, 2025
