FDA Approves Human Trials for Gene-Edited Pig Kidney Transplants (eGenesis)
FDA Approves Human Trials for Gene‑Edited Pig Kidney Transplants In a major step for xenotransplantation, the U.S. Food and Drug Administration has granted Investigational New Drug (IND) clearance to eGenesis to begin human clinical trials of gene‑edited pig kidneys. The approval authorizes a phased clinical study to evaluate safety and efficacy in people with end‑stage kidney disease. What happened The FDA cleared eGenesis to start a three‑phase clinical trial of their CRISPR gene‑edited pig kidneys. Early compassionate‑use transplants (including Tim Andrews and Bill Stewart at Massachusetts General Hospital) have left patients dialysis‑free for months. United Therapeutics is pursuing similar trials using their own gene‑edited pigs. Who is eligible The initial eGenesis trial will enroll people who: Have end‑stage kidney disease (ESKD) Are 50 years or older Are dialysis‑dependent and currently…
