A man who received a pig organ transplant lived with it for a record-setting eight months. Surgeons at Massachusetts General Hospital transplanted a gene-edited porcine kidney to treat Tim Andrews for end-stage kidney disease. Andrews, who had the pig organ removed and returned to dialysis at the end of October, is the longest to have lived with a xenotransplant (an organ transplanted from one species to another). Gene-editing is central to achieving this milestone: it allows scientists to surmount multiple challenges associated with cultivating animal organs to be systemically compatible with humans. Between February 2024 and April 2025, the US Food and Drug Administration (FDA) granted three Investigational New Drug applications (INDs) for xenotransplant clinical trials: to eGenesis, the company that provided the kidney (EGEN-2784) used for Andrews’ transplant, and to United Therapeutics.
Both companies are conducting clinical trials of porcine kidneys that incorporate precise genetic edits to prevent hyperacute immune rejection and modulate immune responses associated with complement activation and inflammation. eGenesis’s IND outlines a phase 1/2/3 trial to evaluate the safety and efficacy of EGEN-2784 at 24 weeks post-transplant in 33 patients with end-stage kidney disease. In September, the FDA granted a trial expansion based on the company’s report of positive data from three patients, including Andrews. Similarly, United Therapeutics received FDA clearance to enroll a clinical cohort of six patients with end-stage kidney disease to receive a UKidney transplant and eventually extend the study to up to 50 participants.
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