The FDA approves human trials for pig kidney transplants

Despite how it sounds, a xenotransplant isn’t something from the latest Alien movie. It’s an increasingly credible science: the transplantation of animal organs into humans. The field took one of its biggest leaps forward on Monday. The FDA approved the biotech company eGenesis to begin human trials of pig-to-human kidney transplants.

eGenesis provides pigs with CRISPR-modified genes. These genetic changes reduce the chances of organ rejection in human recipients. The FDA approved the company for Investigational New Drug (IND) Clearance for a three-phase study. Each stage will increase the number of patients if the results support moving forward.

Only those with end-stage kidney disease will be eligible. They’ll also need to be 50 or older, dialysis-dependent and on the kidney transplant waitlist. Around 86,000 people are currently on the kidney waitlist. The average wait time is three to five years at most centers. It can be longer for rarer blood types. Over 800,000 Americans have end-stage kidney disease.

eGenesis isn’t alone: United Therapeutics, another gene-edited pig developer, will soon begin enrolling people in a similar FDA-approved study.

“Advances in xenotransplantation are giving our community hope that new options may soon be available to those who need them most,” National Kidney Foundation CEO Kevin Longino wrote in a press release. “Patients expressed strong support for the advancement of clinical trials in our recent Xenotransplantation Voice of the Patient report. It is gratifying to know they’re being heard.”

The trial approval coincided with news of another successful xenotransplant. Bill Stewart, an otherwise healthy 54-year-old New Hampshire resident, received one of eGenesis’ pig kidneys on June 14. Before the operation, he received dialysis three times per week for over two years. His organ donor wait was longer than most due to his blood type. He was discharged from Massachusetts General Hospital on June 21 and no longer requires dialysis.

“There’s so few of us who have done this, and they’re writing the protocol as we go, so to speak,” Stewart told CNN. “But I’m feeling good.”

Tim Andrews, 67, received a pig kidney in January. Before his transplant, he required dialysis for over two years. Over seven months after the operation, he’s still dialysis-free. He’s currently the longest living recipient.

Earlier transplant recipients had significant underlying health problems. That limited scientists’ ability to conduct long-term tests. Trials with healthier patients will assess the durability of the organs over time.