U.S. FDA approves breakthrough gene-edited pig kidney xenotransplant trial
Tony Morley, February 14th 2025
A newly approved xenotransplant kidney study could help lay the scientific and commercial groundwork to save tens of thousands of lives for those suffering kidney failure in the United States.
The U.S. Food and Drug Administration (FDA) has approved the first-ever clinical trial for transplanting a genetically modified pig kidney into living human recipients. The trial, planned to begin by the middle of 2025, will see an initial six patients participate, but may scale up to 50 total transplants.
The breakthrough trial aims to evaluate the safety and effectiveness of pig kidney transplants for patients who urgently need a kidney but are either ineligible for a human donor organ or unlikely to receive one within five years. The ultimate goal being to address the critical organ shortage in the United States, as there are currently more than 106,000 people on the national organ transplant waitlist, the majority in need of donor kidneys. As few as 21,000 kidney transplants were successfully preformed in 2023, with roughly 800,000 patients in the United States suffering chronic kidney failure, and some 557,000 patients on dialysis to filter their blood.
"A 2009 study estimated that 52% of kidney transplant candidates who were at least 60 years of age when placed on the transplant waitlist die within five years before receiving a transplant2. United Therapeutics believes that xenotransplantation offers a therapeutic alternative to dialysis."
"United Therapeutics’ xenokidney, known by the proposed trade name UKidney, is an investigational xenokidney from a pig with 10 gene edits. Six human genes are added to the pig genome to facilitate immunological acceptance and compatibility of the organ in the human recipient, while four porcine genes are inactivated: three that contribute to porcine organ rejection in humans and one that can cause organ growth."
Patients in the study, aged age of 55 to 70 years old, will receive a gene-edited xenokidney transplant followed by a 24-week post transplant follow-up period. After the 24-week observation period, patients will be followed for the rest of their lives, to study the safety and function of the transplanted pig kidneys.
If successful, the story could be the start of a scientific and commercial tipping point in the use of pig kidney xenotransplants in the battle against critical shortages in donor organ availability, saving tens of thousands of lives in the United States, and helping lay the groundwork for global adoption.
Tanya Lewis
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