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FDA Clears First Broad Trial of CRISPR-Edited Pig Kidneys in Humans

The decision shifts xenotransplantation from one-off surgeries to regulated testing.

Overview

  • eGenesis received FDA investigational new drug clearance to begin a multi-phase study of its EGEN-2784 pig kidneys in about 30 dialysis-dependent adults aged 50 and older.
  • Massachusetts General Hospital said its third recipient, 54-year-old Bill Stewart, was discharged a week after his June 14 surgery and is back home without dialysis.
  • Tim Andrews, 67, has surpassed seven months dialysis-free after his January transplant, the longest survival yet for a pig kidney in a living person.
  • The donor pigs are engineered with CRISPR to knock out alpha-gal, remove porcine genes tied to rejection, add seven human genes to modulate immunity and coagulation, and inactivate porcine endogenous retroviruses.
  • United Therapeutics is preparing a parallel FDA-cleared study as researchers move to evaluate safety and durability across broader patients to help address a U.S. kidney shortage exceeding 100,000 people on waitlists.