In a major advancement in medical science, the U.S. Food and Drug Administration (FDA) has approved clinical trials for gene-edited pig kidneys to be used in human transplants.
This approval paves the way for biotech companies United Therapeutics and eGenesis to begin trials aimed at tackling the severe organ shortage in the U.S., where more than 100,000 people are currently waiting for transplants, with over 90,000 in need of kidneys.
United Therapeutics, which announced the FDA’s approval, plans to begin enrolling patients with end-stage renal disease in its trial, with the first transplant expected by mid-2025.
The initial study will include six patients, with the potential to expand to 50 participants.
Leigh Peterson, the company’s executive vice president, hailed the approval as a “significant step forward in our relentless mission to expand the availability of transplantable organs.”
Meanwhile, eGenesis, another leader in the field of xenotransplantation (the transplantation of animal organs into humans), received its own FDA approval for a separate trial in December.
This study will focus on three patients with kidney failure who are unlikely to receive a donor kidney within the next five years.
Xenotransplantation has long been a goal for scientists, but challenges such as immune rejection and disease transmission from animals to humans have hampered progress.
However, recent breakthroughs in gene editing and immune system management have brought the field closer to reality.
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Pigs are seen as ideal donors due to their similar organ size and rapid reproduction rates, making them viable candidates for organ transplants.
Participants in the trials will be closely monitored for kidney function, survival rates, and any risk of zoonotic infections, which are diseases that could be transmitted from animals to humans.
The most notable case so far involves Towana Looney, a 53-year-old from Alabama, who became the first living human recipient of a pig kidney in November 2024.
Looney has now survived 71 days with the transplant, setting a new record for pig organ longevity. This follows the 2022 case of David Bennett, who received a pig heart and lived for 60 days.
