FDA Approves First Clinical Trials for Pig Kidney Transplants in Humans
The groundbreaking trials aim to address the organ shortage crisis using genetically modified pig kidneys.
- The FDA has authorized United Therapeutics and eGenesis to conduct clinical trials using genetically modified pig kidneys for human transplants.
- United Therapeutics plans to begin with six patients suffering from end-stage renal disease, with the first transplant expected in mid-2025, and may expand to 50 participants if initial results are promising.
- eGenesis received FDA approval in December 2024 for a smaller trial involving three patients who face low odds of receiving a human kidney within five years.
- The trials aim to provide a solution for over 100,000 people on the U.S. transplant waitlist, including 90,000 in need of kidneys, with 12 people dying daily while waiting for a kidney transplant.
- Participants will be monitored for survival, kidney function, and potential zoonotic infections, marking a significant step forward in xenotransplantation research.