Two US biotech companies say the country's Food and Drug Administration (FDA) has given them permission to conduct clinical trials of genetically edited pig kidneys they are developing for human transplantation.
United Therapeutics and another company, eGenesis, have been conducting research since 2011 on implanting pig kidneys into humans: initially into brain-dead patients, and more recently into living recipients.
Advocates hope the approach will help address a severe organ shortage. More than 100,000 people in the U.S. are waiting for transplants, including more than 90,000 who need kidneys.
The approval for United Therapeutics, announced Monday, opens the door for the company to scale up its technology into a licensed product if the trial is successful.
The study authorization was hailed as a “significant step forward in our ongoing mission to expand the availability of transplantable organs,” said Leigh Peterson, the company’s executive vice president.
The trial will initially include six patients with end-stage kidney disease before expanding to at least 50 people, United Therapeutics said in a statement. The first transplants are expected to occur in mid-2025.
Meanwhile, rival company eGenesis said it received FDA approval in December for a study in three separate kidney patients.
“This study will evaluate whether patients with kidney failure listed for transplantation remain at low risk of receiving an offer from a deceased donor within five years,” the company said.
Xenotransplantation – or transplanting organs from one species to another – has become a huge desire but one that science has struggled to realize.
Early experiments in primates have hit a snag, but advances in genetic editing and immune system management have brought these efforts closer to reality.
Pigs have emerged as ideal donors: they grow rapidly, produce large numbers of offspring, and have become part of the human food supply.
United Therapeutics said trial patients will be monitored throughout their lives, to measure survival rates, kidney function and the risk of zoonotic infections – diseases that spread from animals to humans.
Currently, only one living person has received an organ from a pig: Towana Looney, a 53-year-old woman from Alabama who received a kidney from United Therapeutics on November 25, 2024.
He is also the longest-surviving kidney recipient, having lived with a pig kidney for 71 days, as of Tuesday, February 4, 2025. David Bennet, a Maryland resident, received a pig liver in 2022 and survived for just 60 days.
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