Two American biotech companies announced that they were granted approval by the FDA, the U.S. health agency, to proceed with clinical trials involving pig kidneys for human transplants.
United Therapeutics and eGenesis have been conducting experiments since 2021 to place pig kidneys in humans, starting with patients who have brain death and more recently with living individuals.
The researchers aim to address the lack of available organs for transplantation, as there are over 100,000 individuals in the United States awaiting transplants, with more than 90,000 in need of a kidney.
The approval from the FDA granted to United Therapeutics on Tuesday will enable the company to progress in their technology development for potential product licensing upon successful testing.
The company’s executive vice president, Leigh Peterson, stated that authorization is an important part of their ongoing effort to increase the availability of transplant organs.
Clinical trials will begin with six patients with end-stage kidney disease and will expand to 50 individuals, as reported by United Therapeutics in a statement.
The initial transplant is scheduled for the middle of the year.
eGenesis has already announced that they obtained FDA approval in December for a study involving three patients.
The company stated that the study will assess patients with kidney failure on the waiting list who have a low chance of receiving a deceased donor within five years.
Xenotransplantation, the transfer of organs between different species, remains an unachieved objective in the field of science.
The initial trials with primates were unsuccessful, but advancements in genetic editing and immune system control bring the objective within reach.
Pigs have been found to be excellent donors as they grow quickly, reproduce frequently, and are consumed by humans.
United Therapeutics stated that patients being tested will receive continuous monitoring for life, including assessments of survival rates, kidney function, and the potential for zoonotic infections.
On November 5, 2024, Towana Looney, a 53-year-old individual from Alabama in the United States, became the third recipient of a pig kidney transplant.
Looney is the sole individual to have survived the operation, living for slightly more than 70 days post-transplant. David Bennett from Maryland was transplanted with a pig’s heart in 2022 and lived for 60 days.