Two companies, United Therapeutics and eGenesis, have received FDA approval to conduct clinical trials for transplanting genetically modified pig kidneys into humans1.
United Therapeutics' UKidney™ comes from a 10 gene-edited source pig, while eGenesis uses a 69 gene-edited source pig1.
The United Therapeutics trial is expected to start in mid-2025, initially with six patients and expanding to 50 patients with end-stage renal disease1.
Participants in the United Therapeutics trial must be diagnosed with ESRD, on dialysis for at least six months, and between 55-70 years old1.
The eGenesis trial will start with three patients living with kidney failure who are unlikely to receive a human organ within five years1.
These trials follow three previous pig kidney transplants in humans under compassionate use programs1.
The most recent recipient, Towana Looney, received a gene-edited pig kidney at NYU Langone on Nov. 25, 2024, and is currently the longest-living person with a pig kidney1.
Researchers hope these studies will advance understanding of xenotransplantation as a potential solution to the organ shortage, with over 92,000 Americans on the kidney transplant waiting list1.
Sources:
1. https://www.kidneyfund.org/article/fda-greenlights-first-clinical-trials-genetically-modified-pig-kidney-transplants-humans