FDA Approves Clinical Trials for Genetically Modified Pig Kidney Transplants
Conexiant
February 4, 2025
The FDA has approved clinical trials for genetically modified pig kidney transplants in patients with end-stage renal disease, starting in 2025.
United Therapeutics and eGenesis will conduct trials to evaluate the long-term viability and immunogenic compatibility of xenotransplantation.
United Therapeutics plans to enroll 6 patients initially, expanding to 50 if early safety and efficacy endpoints are met.
eGenesis will start with three patients and increase enrollment in a staggered manner, monitoring health outcomes for 24 weeks post-transplant.
Ethical concerns include informed consent for dialysis patients and potential zoonotic pathogen transmission risks associated with xenotransplantation.
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