Genetically engineered pig kidney transplant trial gets the OK
A Cambridge biotech company and Boston doctors have received federal approval to start the nation’s first clinical trial of genetically engineered pig kidney transplants in people with end-stage kidney disease.
Researchers say this development could eventually help ease the country’s critical organ shortage.
The approval builds on procedures at Massachusetts General Hospital, part of the Mass General Brigham system. Last year, Rick Slayman, 62, of Weymouth, became the first person to successfully receive a genetically modified pig kidney. He died less than two months after the surgery at Mass General in what his medical team described as a cardiac event.
Now, the Food and Drug Administration has cleared eGenesis to begin testing EGEN-2784, a pig kidney altered with multiple genetic edits to make it more compatible with the human body. (Slayman’s surgery was performed under a single “compassionate use” FDA Expanded Access Protocol, referred to as which is granted to a single patient or group of patients with serious, life-threatening illnesses or conditions to gain access to experimental treatments or trials when no comparable treatment options or therapies exist.)
The study will enroll more than 30 patients age 50 and older who rely on dialysis and are on the transplant waitlist, expanding access to transplant centers nationwide, according to Patriot Ledger media partner WCVB.
“Clearance of the EGEN-2784 IND and initiation of this clinical study are important steps forward in our mission to end the global organ shortage,” eGenesis President and CEO Mike Curtis said in the company’s announcement.
Success stories of genetically engineered pig kidney transplants
Tim Andrews, 67, of Concord, New Hampshire, received an EGEN-2784 kidney in January and recently passed the seven-month mark without dialysis, according to eGenesis, and WCVB reported that he even threw out the first pitch at Fenway Park in June.
On June 14, 54-year-old Bill Stewart, an athletic trainer from Dover, New Hampshire, became the second patient in the study and the third overall to receive an EGEN-2784 kidney. The eGenesis statement said he was discharged a week later and is off dialysis for the first time in more than two years.
“I’m so appreciative of the MGH transplant team for giving me this opportunity and a new lease on life,” Stewart said in the eGenesis statement.
When will genetically engineered pig kidney transplants be more available?
Dr. Leonardo V. Riella, medical director for kidney transplantation at MGH and the study’s lead investigator, called the progress “nothing short of groundbreaking.” In an interview with WCVB, he described the FDA’s decision as “a big milestone,” saying it could allow transplant centers across the country to offer the procedure under research protocols, though widespread availability is likely years away.
According to the American Kidney Fund, more than 800,000 Americans live with end-stage kidney disease. Just 28,000 kidney transplants were performed nationwide in 2024, according to eGenesis. For those unable to receive a donor kidney, dialysis remains the only option, with a five-year survival rate just over 50 percent.
Kevin Longino, CEO of the National Kidney Foundation and a transplant recipient, said in the eGenesis statement that patients have voiced strong support for moving ahead with trials, adding that the FDA’s decision gives them “hope that new options may soon be available to those who need them most.”
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