NEW YORK — September 9, 2025 —
A major step in medical science: The FDA has cleared the way for human trials of pig-to-human kidney transplants.
- The FDA has approved eGenesis to start human trials for pig-to-human kidney transplants.
- These trials aim to help patients with end-stage kidney disease who are on the waitlist.
- eGenesis uses CRISPR-modified pig genes to reduce organ rejection.
- Recent successful xenotransplants offer hope for new treatment options.
Have you heard about xenotransplantation? It sounds like science fiction, but it’s a rapidly advancing field involving the transplantation of animal organs into humans. On Monday, the U.S. Food and Drug Administration (FDA) cleared a significant hurdle, approving biotech company eGenesis to begin human trials for pig-to-human kidney transplants.
eGenesis genetically modifies pigs using CRISPR technology. These modifications are designed to significantly lower the risk of organ rejection in human recipients. The FDA’s approval grants the company Investigational New Drug (IND) Clearance for a phased study. This approach will allow for an increasing number of patients to participate as the trial progresses, contingent on positive early results.
Who Qualifies for the Trial?
Eligibility for the trial is specifically for individuals with end-stage kidney disease. Candidates must also be 50 years of age or older, currently dependent on dialysis, and on the national kidney transplant waitlist. Approximately 86,000 people are currently awaiting a kidney transplant. The typical wait time at most medical centers is three to five years, with longer waits possible for those with rarer blood types. In total, over 800,000 Americans are living with end-stage kidney disease.
This isn’t the only advancement in the field. United Therapeutics, another company developing gene-edited pigs for transplantation, is also preparing to enroll patients in a similar, FDA-approved study.
“Advances in xenotransplantation are giving our community hope that new options may soon be available to those who need them most,” said Kevin Longino, CEO of the National Kidney Foundation, in a press release. “Patients expressed strong support for the advancement of clinical trials in our recent Xenotransplantation Voice of the Patient report. It is gratifying to know they’re being heard.”
Recent Successes Offer Glimmers of Hope
The FDA’s trial approval comes on the heels of encouraging news about another successful xenotransplant. On June 14, Bill Stewart, a 54-year-old resident of New Hampshire, received one of eGenesis’ genetically modified pig kidneys. Before the procedure, Stewart had been undergoing dialysis three times a week for over two years. His wait for an organ was prolonged due to his specific blood type.
Stewart was discharged from Massachusetts General Hospital on June 21, and importantly, he no longer requires dialysis. “There’s so few of us who have done this, and they’re writing the protocol as we go, so to speak,” Stewart told CNN. “But I’m feeling good.”
Another patient, Tim Andrews, 67, received a pig kidney in January. He had also been on dialysis for over two years prior to the transplant. Now, more than seven months post-operation, he remains dialysis-free, marking him as the longest-living recipient of such a transplant to date.
Previous xenotransplant recipients often had significant underlying health conditions. These complexities made it difficult for researchers to assess the long-term performance and durability of the transplanted organs. Trials involving healthier patients, like Stewart and Andrews, are crucial for understanding how these animal-derived organs function over extended periods.
