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The first successful transplant of both a pig kidney and heart pump implant into a living person, announced Wednesday, marked a significant milestone for Silver Spring’s United Therapeutics Corp.
United Therapeutics (NASDAQ: UTHR) is behind the genetically modified pig kidney that a 54-year-old New Jersey woman received earlier this month because she had too many chronic health problems, including kidney and heart failure, to qualify for human organs. She was the first person to receive what’s called a xenothymokidney, a kidney that also contains tissue from the pig’s thymus. The kidney, with that tissue, is designed to make the body less likely to reject the organ.
The procedure was completed on April 12 but not disclosed until Wednesday.
Blacksburg, Virginia’s Revivicor Inc., a UT subsidiary, developed the organ. It has been behind two transplants of genetically modified pig hearts into human patients, the first who died after about two months and the second who died after six months. It has also developed genetically altered organs that were transplanted into several brain-dead recipients, the first of which was in 2021.
“This historic transplant builds on the base of knowledge that the teams at United Therapeutics and our academic collaborators have established over the past two decades and demonstrates the potential utility for xeno organs to revolutionize the way patients with end-stage organ disease are managed in the future,” Leigh Peterson, executive vice president for product development and xenotransplantation at UT, said in a statement.
Dr. Robert Montgomery led the surgery at NYU Langone Health. Regulators authorized the procedure under what’s called an expanded access pathway, which allows patients with life-threatening conditions to access experimental therapies and products.
United Therapeutics is now running preclinical studies required by the Food and Drug Administration, with a goal to start clinical trials in humans in 2025, Peterson said.
United Therapeutics has garnered global attention for its trailblazing work in the organ manufacturing arena. That work covers xenotransplantation, or the transplant of organs between species; ex vivo lung perfusion, the process of keeping lungs alive outside of the body before they can be greenlit for transplant; and 3D printing to develop manufactured lungs and kidneys. Earlier this year, UT opened a facility in Christiansburg, Virginia — where it plans to run clinical trials once getting the FDA’s OK to start.
It’s all with an eye toward addressing the organ shortage, which leaves people with end-stage diseases without options. The Health Resources and Services Administration reports that more than 100,000 Americans are waiting for organ transplants and 17 people die each day before getting one.
