FDA Approves First Xenotransplant Trial of Gene-Edited Pig Kidney

United Therapeutics announced that the FDA has granted the company approval to begin a first-in-human clinical study of a gene-edited pig kidney. The study focuses on UKidney, which is derived from a 10-gene–edited source pig.

The purpose of the multicenter, open-label study is to determine the efficacy and safety of UKidney to support FDA approval of a Biologics License Application. The study will initially enroll six patients and expand to up to 50 participants.

Participants will come from two groups: patients with end-stage renal disease (ESRD) who have been assessed and determined to be ineligible for a conventional allogeneic kidney transplant for medical reasons and patients with ESRD who are on the kidney transplant waitlist but are more likely to die or go without a transplant than receive a deceased donor kidney transplant within five years.

The first xenotransplant in the trial is expected to occur in mid-2025.

Source: Press release