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.
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 Leigh Peterson, the company’s executive vice president of product development and xenotransplantation, in a statement.
Last year, doctors successfully transplanted a genetically edited pig kidney produced by eGenesis Inc. 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.
About The Author
