Following an initial 12-week observation period for these first six patients, the trial may expand to include up to 50 participants, depending on the results.

Due to the experimental nature of xenotransplantation, regulatory requirements for clinical trials often involve extensive safety and efficacy data from prior animal studies.

For the past three years, United Therapeutics and eGenesis have been conducting pig organ transplants under compassionate use waivers, providing treatments for patients without viable options.

The renewed interest in genetically modified animal organs as a solution for organ donation shortages is driven by advancements in gene-editing technologies, particularly CRISPR.

However, the risks involved in these procedures are underscored by previous cases where some patients who received pig organs died shortly after the transplant.

United Therapeutics expects to perform its first organ transplant for the trial around mid-2025, marking a significant advancement in the field of xenotransplantation.

The trial will focus on kidney transplants, beginning with six patients suffering from end-stage renal disease.

United Therapeutics has received FDA clearance to initiate the first clinical trial testing organ transplants from gene-edited pigs for patients in need of transplants.

The study aims to assess patient survival, kidney function, and quality of life over a 24-week period, with lifelong follow-up for all participants.

Eligible participants include those who cannot receive a human kidney transplant for medical reasons or who are at high risk of dying before receiving a deceased donor kidney.

United's gene-edited pigs have undergone ten genetic modifications, while eGenesis has implemented a greater number of edits and plans to seek FDA approval for its own kidney trial later in 2025.