United Therapeutics Announces Recent Milestones for its Heart and Kidney Xenotransplantation Programs - Seite 2

Second Successful Xenoheart Transplant Conducted at the University of Maryland Medical Center

In the second procedure of its kind, surgeons affiliated with UMM last Wednesday transplanted a UHeart from a 10-gene modified pig into Mr. Lawrence Faucette, under an emergency approval from the U.S. Food and Drug Administration (FDA). According to the transplant team, a xenoheart transplant was the only option available for Mr. Faucette, who has end-stage heart disease and was deemed ineligible for a traditional transplant with a human heart due to his pre-existing peripheral vascular disease and complications with internal bleeding. Mr. Faucette was facing near-certain death from heart failure.

United Therapeutics’ UHeart is a heart from a pig with 10 genetic modifications to support organ functioning in the human body. Six human genes were added to the pig genome to facilitate immune acceptance of the organ, while four genes were knocked out: three that contribute to porcine organ rejection in humans and one that can cause organ growth beyond what is normal for humans. United Therapeutics is also developing the UKidney, a kidney from the same 10-gene modified pig.

“The second transplantation of a UHeart into a living person and the extended study of a UThymoKidney in a decedent, coupled with other ground-breaking research by our collaborators at the University of Alabama at Birmingham, University of Maryland Medicine, and NYU Langone Health, form the basis of knowledge we are sharing with the FDA ahead of commencing future clinical studies of xeno organs in humans,” said Leigh Peterson, Ph.D., Executive Vice President, Product Development & Xenotransplantation at United Therapeutics. “We look forward to continuing our dialogue with the FDA with the goal of starting clinical studies in 2025.”

Dr. Peterson continued: “We are grateful for the courageous contribution of Mr. Faucette and his family to the advancement of this important science. The entire United Therapeutics family is pulling for Mr. Faucette and hopeful for a smooth recovery.”

United Therapeutics is preparing for clinical trials of its xenoheart and xenokidney products, following completion of ongoing preclinical studies required by the FDA.

Xenokidney Demonstrates the Longest-Documented Case of Xeno Organ Function in a Human Body at NYU Langone Medical Center

In a 61-day study that concluded September 13th, surgeons at NYU Langone Medical Center evaluated the function of a UThymoKidney in what is now the longest-documented case of a xeno organ functioning in a human body. The kidney recipient, with his family’s consent, was a deceased 58-year-old man who had been on a ventilator after being declared dead by neurologic criteria before the xenotransplant.