The first clinical trial to transplant pig kidneys into people is underway, offering potential new hope for patients in need of kidney replacements. United Therapeutics, which develops gene-edited pig kidneys, announced that the initial transplant at NYU Langone Health was completed successfully.
Experts describe the effort as a landmark in xenotransplantation, the field studying animal-to-human organ transfers. A second company, eGenesis, plans to launch its own pig kidney trial in the coming months. These are the earliest known clinical tests of this approach.
To protect participant identity, researchers have not released details about the NYU surgery date or other patient information.
Dr. Robert Montgomery of NYU, who led the transplant team, told The Associated Press that the hospital has a roster of additional patients interested in joining the small trial, which will begin with six participants. If results are favorable, the study could expand to as many as 50 patients as more transplant centers join.
The Food and Drug Administration approved these rigorous studies after a series of compassionate-use experiments, which yielded mixed outcomes. The first two gene-edited pig kidney transplants were short-lived.
In earlier experiences, doctors treated patients with severe kidney failure who were not as sick as initial transplant recipients. At NYU, an Alabama woman’s pig kidney lasted 130 days before dialysis was required again. The most recent record, 271 days, was set by a New Hampshire man transplanted at Massachusetts General Hospital; his pig kidney eventually declined and was removed, and he returned to dialysis. Other living recipients include a Mass General patient and a woman in China.
“This is moving in the right direction,” Montgomery said, noting that learning from each patient’s experience is essential. He added that the option to resume dialysis provides a safety net for participants.
More than 100,000 people in the United States are on the kidney transplant list, and thousands die while waiting. Scientists are also pursuing genetic modifications of pigs to make their organs more compatible with human biology, reducing immune rejection risks and improving success rates.
United Therapeutics’ trial involves pig kidneys engineered with ten gene edits to prevent early rejection and overgrowth, while adding human genes to enhance compatibility.
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