Successful Swine Kidney Transplant Offering Potential Life-Saving Solutions for Thousands, Asserts FDA
In a monumental stride for medical history, two human clinical trials using gene-edited pig kidneys are currently underway, marking the first time such trials have been conducted simultaneously.
On June 14, 2023, 54-year-old Bill Stewart received a kidney transplant at Massachusetts General Hospital, becoming the first recipient in one of these trials. The specific version of the pig kidney transplanted, EGEN-2784, was developed by the biotech company eGenesis.
The approach used by eGenesis relies on CRISPR technology to remove a pig gene that produces a carbohydrate called alpha-gal, making the kidney more likely to survive in a human host. Additionally, the genes of the pigs have been edited to reduce immune rejection and inactivate porcine endogenous retroviruses.
The pig kidneys used in these procedures come from biosecure facilities. If the trial proceeds smoothly, EGEN-2784 could become the first gene-edited pig organ to receive FDA approval for general use.
eGenesis, led by President and CEO Mike Curtis, Ph.D., plans to treat 30 patients over the next two and a half years as part of these clinical trials. The goal is to move from emergency, one-off surgeries to rigorously controlled trials, with patients 50 or older, with end-stage kidney disease, and dependent on dialysis being eligible.
Another biotech company, United Therapeutics, is preparing its own trial this year with up to 50 patients. These patients must also be on the transplant waitlist, which currently includes about 86,000 people waiting for a kidney. The average wait time for a kidney transplant in the U.S. is three to five years, but for people with Type O blood, it can stretch to a decade.
Not all transplanted organs have been successful. Towana Looney, a transplant recipient, lived dialysis-free for 130 days before an unrelated infection required the kidney's removal. Tim Andrews, 67, was the first patient in the eGenesis program and has been living without dialysis for more than seven months after receiving a gene-edited pig kidney in January 2025.
The first pig kidney transplant at Mass General occurred in March 2024, with the recipient, 62-year-old Rick Slayman, dying two months later due to unrelated cardiac issues, not organ failure. The pig kidney transplant performed on 54-year-old Lisa Pisano at NYU Langone in April 2024 was also under a compassionate use protocol.
These groundbreaking trials represent a turning point in the field of medicine, with the FDA approving the first-ever human clinical trials using gene-edited pig kidneys. It is hoped that these trials will pave the way for a future where organ shortages are alleviated, and more lives can be saved.
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