The FDA has given a green light to human trials for pig kidney transplants, a major step forward for the field of xenotransplantation. This is not science fiction but a rapidly advancing science that could offer new hope to hundreds of thousands of patients.
The biotech company eGenesis received Investigational New Drug clearance from the FDA to begin a three-phase study. The company uses pigs that have been genetically modified using CRISPR technology. These edits are designed to make the animal organs more compatible with the human body and significantly reduce the risk of rejection.
Eligibility for the trial is strictly limited to patients who are most in need. Participants must be 50 or older, diagnosed with end-stage kidney disease, dependent on dialysis, and already on the national kidney transplant waitlist. This addresses a critical shortage, as approximately 86,000 people are currently waiting for a kidney, with average wait times stretching three to five years or longer. Over 800,000 Americans are living with end-stage kidney disease.
eGenesis is not the only company in this space. United Therapeutics, another developer of gene-edited pigs, is also preparing to enroll patients in a similar FDA-approved study.
This trial approval comes alongside news of another successful procedure. Bill Stewart, a 54-year-old from New Hampshire, received a pig kidney from eGenesis on June 14. After relying on dialysis three times a week for over two years, he was discharged from Massachusetts General Hospital just one week after his transplant and is now dialysis-free. He noted that while the process is new, he is feeling good.
Another recipient, 67-year-old Tim Andrews, received a pig kidney in January. Over seven months later, he remains off dialysis and is currently the longest-living recipient of such a transplant. Earlier patients had more complex health issues, which limited long-term study. These newer cases with healthier individuals will provide crucial data on the durability and long-term functionality of these organs.
The National Kidney Foundation expressed strong support for these advancements. CEO Kevin Longino stated that these advances give the community hope and that patients have been vocal in their support for moving forward with clinical trials. This milestone represents a significant convergence of genetic science and medicine, potentially heralding a new era for treating organ failure.
