FDA Approves Clinical Trials for Pig Kidney Transplants in Humans
The US Food and Drug Administration has greenlit clinical trails for organ transplants from genetically modified pigs. The study led by United Therapeutics Corp will begin with six patients facing end-stage renal disease — eventually being expanded to include 50 kidney failure patients. The first transplant is expected to occur in mid-2025.
According to a statement released by the company on Monday, patients will receive a UKidney transplant followed by a 24-week post-transplant follow-up period. Participants will continue to be followed for the rest of their lives — including for survival, UKidney function, and monitoring for zoonotic infections4 — during this time.
The first cohort will comprise of six transplants at two centers — with a 12-week waiting period between the first and second transplants. Data will be reviewed after this group of patients reaches at least 12 weeks post-transplant in order to determine whether the study should continue.
United Therapeutics has also indicated plants to engage with the FDA after the first six transplants are completed. If safety and efficacy results are supportive, the sample size will be increased to a total of up to 50 participants to enable the study to support registration, with additional transplant centers expected to be added to the study.
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 Centers 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.
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