FDA clears eGenesis to test a genetically engineered pig kidney in 33 people

FDA clears eGenesis to test a genetically engineered pig kidney in 33 people

On September 3, eGenesis reported that five patients with kidney failure had received its genetically engineered pig kidney, EGEN-2784, through an expanded access program. In three patients, the transplanted kidney functioned for more than eight months without dialysis. The company expects to begin a trial in 2027 involving 33 people on the waiting list for a human kidney.

People with severe kidney failure need regular dialysis to filter their blood or must wait for a donor kidney. In its September 3 press release, eGenesis, the developer of EGEN-2784, reports that five patients have received the kidney since March 2024 through an expanded access program for experimental treatment. In three patients, the kidney functioned for more than eight months without dialysis, including one for more than nine months. Two patients subsequently received human donor kidneys.

Xenotransplantation is the transplantation of an animal organ into a human. One patient's transition from a pig kidney to a human kidney is described in detail in an article in the medical journal The Lancet. Tim Andrews received a pig kidney on January 25, 2025, and remained free of dialysis for 271 days. Damage to small blood vessels caused the transplanted kidney to lose function, and it was removed. After 82 days, Andrews received a human kidney, which began functioning immediately.

Three pig antigens, molecules that the immune system uses to recognize foreign tissue, have been removed from the cells of EGEN-2784. According to eGenesis, seven added human genes are intended to regulate the immune response, inflammation and blood clotting.

eGenesis reports that the FDA has cleared the RESTORE trial to enroll 33 patients aged 50 to 70 who are already on the waiting list for a human kidney. The company expects to begin the study in the first quarter of 2027.