United Therapeutics in downtown Silver Spring has received regulatory approval to begin clinical trials for pig-to-human kidney transplants.
The Food and Drug Administration has granted the company permission to begin trials of its investigational product, UKidney, which is derived from a genetically modified pig.
The initial study will enroll six patients with end-stage renal disease, with the potential to expand to 50 participants, and aims to support a Biologics License Application to the FDA.
According to a press release, United Therapeutics expects the first xenotransplant in the trial to occur around midyear.
The FDA approval “represents a significant step forward in our relentless mission to expand the availability of transplantable organs,” said Leigh Peterson, UT’s Executive Vice President of Product Development and Xenotransplantation. “Our goal is to increase the availability of transplantable organs to offer a therapeutic alternative to a lifetime on dialysis for a large population of patients who are unlikely to receive an allogeneic kidney transplant.”
UT has gained global recognition for its groundbreaking work in organ manufacturing, achieving several significant milestones last year. These include the first-ever transplant of a xenothymokidney into a living human recipient, the first combined mechanical heart pump and organ transplant, and the first xenotransplant into a living human using only FDA-approved immunosuppressive medications.
The company’s UThymoKidney transplant procedure conducted last year followed two successful pig-to-human heart transplants by UT in 2022 and 2023.
According to the Washington Business Journal, UT’s research also encompasses ex vivo lung perfusion, which involves keeping lungs viable outside the body before they are approved for transplant. Additionally, the team is engaged in 3D printing to develop manufactured lungs and kidneys.
The innovative work addresses the organ shortage affecting individuals with end-stage diseases. The American Kidney Fund reports that over 557,000 Americans are on dialysis, 808,000 are living with kidney failure, and more than 93,000 are awaiting transplants.
Photo: © “United Therapeutics 06” by Farragutful is licensed under CC BY-SA 4.0.