Successful Swine Kidney Transplant Offers Hope for Thousands, as FDA Contemplates Wide-Ranging Implications
In a historic first, the Food and Drug Administration (FDA) has approved the first-ever human clinical trials using gene-edited pig kidneys. Two concurrent trials are currently underway, marking a significant milestone in medical history.
On June 14, 20XX, Bill Stewart, a patient at Massachusetts General Hospital, became the first recipient of a genetically modified pig kidney in these trials. The kidney, known as EGEN-2784, was developed by the biotech company, eGenesis. This specific version of the pig kidney has been genetically modified using CRISPR to remove a pig gene that produces a carbohydrate called alpha-gal, a key factor in minimising immune rejection.
Tim Andrews, 67, was the first patient in the eGenesis program and has survived more than seven months without dialysis after receiving a pig kidney in January 2025.
Another biotech company, United Therapeutics, is also preparing its own trial. United Therapeutics plans to begin its trial this year with up to 50 patients. If the trial proceeds smoothly, EGEN-2784 could become the first gene-edited pig organ to receive FDA approval for general use.
The pig kidneys used in these procedures come from animals bred in biosecure facilities. Their genes have been edited to reduce immune rejection and inactivate porcine endogenous retroviruses.
Notably, only patients 50 or older, with end-stage kidney disease and dependent on dialysis, will be eligible for the trials. For the first time in medical history, these patients must also be on the transplant waitlist.
The goal is to move from emergency, one-off surgeries to rigorously controlled trials. If successful, these trials could provide a lifeline for the over 86,000 people currently waiting for a kidney transplant. Even if a pig kidney provides just one or two years of dialysis-free life, it could buy patients valuable time.
Post-transplant, Bill Stewart has returned to his two jobs, one of which involves working with people with disabilities. He recently visited his old dialysis clinic not as a patient, but as proof of what's possible.
These groundbreaking trials mark a new era in organ transplantation, offering hope to those in dire need. As we move forward, the focus remains on the safety and efficacy of these treatments, ensuring a brighter future for those on the transplant waitlist.
