09Sep 2025 by alex No Comments

FDA Approves Human Trials for Gene‑Edited Pig Kidney Transplants

In a major step for xenotransplantation, the U.S. Food and Drug Administration has granted Investigational New Drug (IND) clearance to eGenesis to begin human clinical trials of gene‑edited pig kidneys. The approval authorizes a phased clinical study to evaluate safety and efficacy in people with end‑stage kidney disease.

What happened

The FDA cleared eGenesis to start a three‑phase clinical trial of their CRISPR gene‑edited pig kidneys.
Early compassionate‑use transplants (including Tim Andrews and Bill Stewart at Massachusetts General Hospital) have left patients dialysis‑free for months.
United Therapeutics is pursuing similar trials using their own gene‑edited pigs.

Who is eligible

The initial eGenesis trial will enroll people who:

Have end‑stage kidney disease (ESKD)
Are 50 years or older
Are dialysis‑dependent and currently on a kidney transplant waitlist

Why this matters

There are roughly 86,000 people on the U.S. kidney transplant waitlist and over 800,000 Americans with ESKD. Pig organs, from extensively gene‑edited animals designed to reduce rejection and eliminate dangerous porcine viruses, could dramatically expand the organ supply if proven safe and durable.

Early patient outcomes

Two notable patients who received pig kidneys under compassionate or early access programs were discharged dialysis‑free: Bill Stewart (June transplant) and Tim Andrews (January transplant, dialysis‑free for 7+ months). Researchers hope trials with healthier patients will provide stronger data on long‑term durability.

What do you think?

Is xenotransplantation a necessary breakthrough to solve organ shortages, or does it raise too many risks and ethical questions? Share your thoughts below.

Note: This post summarizes recent news and official FDA documentation. It does not include third‑party RSS links or site reviews.

FDA Approves Human Trials for Gene-Edited Pig Kidney Transplants (eGenesis)