Tuesday, February 4, 2025 - Two U.S. biotech companies, United Therapeutics and eGenesis, have received clearance from the Food and Drug Administration (FDA) to conduct clinical trials of gene-edited pig kidneys for human transplants. The groundbreaking approval marks a critical step in efforts to address the severe organ shortage in the United States, where over 100,000 people await transplants, including more than 90,000 in need of kidneys.
United Therapeutics, which announced its FDA approval, plans
to enroll six patients with end-stage renal disease in its initial trial, with
the first transplant expected by mid-2025. The trial could eventually expand to
50 participants. Leigh Peterson, the company’s executive vice president, called
the authorization a “significant step forward in our relentless mission to
expand the availability of transplantable organs.”
eGenesis, another leading player in xenotransplantation,
revealed it had received FDA approval in December for a separate trial
involving three patients with kidney failure. The study focuses on individuals
who are unlikely to receive a deceased donor kidney within five years.
Xenotransplantation, or the transplantation of organs from
one species to another, has long been a goal of medical science. While early
experiments using primates were largely unsuccessful, recent advancements in
gene editing and immune management have brought the field closer to viability.
Pigs are considered ideal donors due to their rapid growth, large litters, and
established role in the human food supply.
United Therapeutics stated that trial participants will be
monitored for life to assess kidney function, survival rates, and the risk of
zoonotic infections, which are diseases that can jump from animals to humans.
Currently, the only living human recipient of a pig organ is
Towana Looney, a 53-year-old from Alabama, who received a United Therapeutics
pig kidney on November 25, 2024. Looney has now survived 71 days with the
organ, making her the longest-living recipient of a pig organ. By comparison,
David Bennett of Maryland received a pig heart in 2022 and survived 60 days.
Both cases underscore the potential of xenotransplantation as a transformative
solution to organ shortages.
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