The procedure was carried out by surgeons at NYU Langone Health and was authorised by the FDA under the expanded access pathway
United Therapeutics reports first use of UThymoKidney in living being. (Credit: Sasin Tipchai from Pixabay)
US-based biotechnology company United Therapeutics has reported the world’s first successful transplant of its xenothymokidney, dubbed UThymoKidney, into a living recipient.
UThymoKidney is an investigational stage xenokidney derived from a pig with a single genetic edit. It is combined with tissue from the pig’s thymus.
The incorporation of the pig’s thymus tissue aims to train the recipient human’s immune system to identify the UThymoKidney as part of his or her own body, thus decreasing the risk of rejection.
Authorised by the US Food and Drug Administration (FDA) under the expanded access pathway, the procedure was carried out by surgeons at NYU Langone Health.
The patient, a 54-year-old woman from New Jersey, was suffering from heart and kidney failure. The recipient was ineligible for conventional heart and kidney transplants due to several chronic medical conditions and the scarcity of suitable human organs.
United Therapeutics said that the transplantation is the first-ever combined procedure involving a mechanical heart pump and organ transplantation.
Additionally, this represents the first-ever xenotransplant into a living human using only FDA-approved immunosuppressive drugs.
It is also the third xenotransplantation procedure using the biotechnology company’s xeno organs. The transplant follows the successful UHeart transplants conducted at the University of Maryland Medicine in 2022 and 2023.
United Therapeutics product development and xenotransplantation executive vice president Leigh Peterson said: “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 revolutionise the way patients with end-stage organ disease are managed in the future.
“We look forward to continuing our dialogue with the FDA with the goal of starting human clinical studies for xenotransplantation in 2025.”
United Therapeutics started its xenotransplantation research in 2011 and presently has a workforce of nearly 50 scientists and support personnel.
The biotechnology company is advancing xenotransplant science across the UHeart xenoheart, the UThymoKidney, and the UKidney organ programmes.
United Therapeutics is now planning for clinical trials of its xenokidney, xenothymokidney, and xenoheart products, following the completion of ongoing preclinical studies mandated by the FDA.