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FDA Clears eGenesis Human Trial of Gene-Edited Pig Kidneys After Record Patient Milestone

The study will enroll older dialysis patients to evaluate CRISPR-edited EGEN-2784 kidneys engineered to reduce rejection risk.

Overview

  • Massachusetts General Hospital reported a third experimental transplant: 54-year-old Bill Stewart received a pig kidney on June 14, was discharged a week later, and is back to work without dialysis.
  • Tim Andrews, 67, remains alive and dialysis-free more than seven months after his January surgery, the longest reported survival of a pig organ in a living person.
  • FDA investigational clearance moves xenotransplantation from isolated compassionate-use cases into a regulated clinical study.
  • The eGenesis trial plans to treat about 30 people age 50 or older who are on dialysis, while United Therapeutics prepares a similar FDA-approved study to expand testing.
  • Donor pigs are deeply engineered: antigens such as alpha-gal are knocked out, multiple human genes are added, and endogenous retroviruses are inactivated to lower rejection and infection risks.