US FDA greenlights studies of pig kidney transplants in humans

The US Food and Drug Administration approved clinical trials that will transplant organs from genetically modified pigs into patients with kidney failure. 

United Therapeutics will initially include six people with end-stage renal disease in the study, eventually enrolling 50 patients, according to a statement on Feb 3.

The patients will receive the company’s UKidney, followed by a 24-week post-transplant period that will include a safety assessment. Participants will then be tracked for the rest of their lives in order to determine survival, kidney function and other factors. 

The first transplant is expected to occur mid-2025.

The studies could be a breakthrough for people needing a kidney transplant. More than 37 million Americans are estimated to have chronic kidney disease, according to 2021 data from the US Centres for Disease Control and Prevention.

Patients in need of a kidney transplant can wait for as long as five years before the procedure, with a risk of complications arising during that time. An estimated 12 people die each day while waiting for a kidney, according to the National Kidney Foundation. 

United Therapeutics’ goal is to increase the number of organs available for transplant to “offer a therapeutic alternative to a lifetime on dialysis for a large population of patients” who are unlikely to receive a kidney from a human donor, said Dr Leigh Peterson, the company’s executive vice-president of product development and xenotransplantation, in a statement. 

In 2024, doctors successfully transplanted a genetically edited pig kidney produced by eGenesis using Crispr gene-editing technology into a 62-year-old man for the first time. The man died two months later, but the hospital where he received the transplant said there was no indication the transplant was the cause. BLOOMBERG