The Food and Drug Administration (FDA) has approved clinical trials that could significantly alter the landscape of organ transplantation.
Two biotechnology companies, United Therapeutics and eGenesis, have received the green light to use genetically modified pig organs for kidney transplants in patients suffering from kidney failure.
The trials aim to offer hope to thousands of patients on the waiting list for kidney transplants, a list that has grown increasingly long due to the severe shortage of donor organs.
United Therapeutics is set to begin its trial in mid-2025, initially involving six patients who have been on dialysis for at least six months. The trial could expand to include up to 50 participants, particularly focusing on patients who are unlikely to receive a human donor kidney within five years due to medical complications. Meanwhile, eGenesis, another biotech company, has received FDA approval for a separate trial involving three patients, with the option to expand based on initial results.
This innovative approach is based on advancements in xenotransplantation, which involves transplanting organs from one species to another. The use of pig organs has gained traction in recent years, with genetically modified pigs created to reduce the risk of rejection when transplanted into humans. Pigs are considered to be a suitable option because their organs share many similarities with human organs, and they are easier to source than some other animals, such as primates.
While this technology offers a potentially life-saving solution, it is not without concerns. Medical ethicists have raised questions about the long-term risks of using animal organs in humans, particularly the possibility of transferring animal-specific diseases or pathogens. However, both United Therapeutics and eGenesis have ensured that their pigs are raised in pathogen-free environments, undergoing regular screenings for harmful microorganisms.
The trials come as the US faces an urgent need for kidney transplants. More than 106,000 people are currently on the waiting list for organ transplants in the United States, with kidney failure being the leading cause. However, in 2023, only about 27,000 kidney transplants were performed, leaving many patients dependent on dialysis or waiting years for a donor kidney.
The approval of these trials marks a significant milestone in the field of xenotransplantation, with the potential to alleviate the burden on the transplant waiting list. The use of genetically modified pig kidneys could open the door to a broader range of organ donations, offering patients an alternative to the lengthy waiting periods currently faced in human organ transplantation.
However, even if the trials are successful, questions remain about the cost of such procedures and whether insurance companies will cover them. There are also ongoing concerns about the ethical implications of using animal organs, especially when it comes to fully informed consent from patients.
The Washington Post and the New York Times contributed to this report.
