FDA Approves First Large-Scale Human Trials of Pig Kidney Transplants

FDA Approves First Large-Scale Human Trials of Pig Kidney Transplants
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Scientists are moving closer to making pig organ transplants a viable option for patients, as the US Food and Drug Administration has approved large-scale clinical trials of genetically modified pig kidneys, CNN reported. The decision allows biotech firm eGenesis to begin testing its organs in humans, marking a significant step in xenotransplantation.

The eGenesis pigs are gene-edited with CRISPR technology to remove the alpha-gal carbohydrate, which would otherwise trigger immediate organ rejection. Until now, such procedures have only been performed under “compassionate use” rules for patients with no other treatment options.

Massachusetts General Hospital recently completed its third experimental pig kidney transplant, with recipient Bill Stewart, 54, returning home and resuming work. Earlier patients included Rick Slayman, the first living recipient of a pig kidney, who died of unrelated cardiac issues, and Tim Andrews, currently the longest-living pig kidney recipient.

NYU Langone and the University of Maryland have also tested pig kidneys and hearts in emergency cases. More than 100,000 Americans await organ transplants, with 86% needing kidneys. Average wait times range from three to five years, but can stretch to a decade for patients with type O blood. Dialysis, the only alternative, carries a five-year mortality rate above 50%.

EGenesis aims to transplant 33 patients over the next two and a half years, while United Therapeutics, another biotech company, plans a trial involving up to 50 patients later this year. Researchers say these larger trials will help determine how pig organs perform across diverse patient populations, including healthier candidates.

Experts believe the trials could provide a breakthrough in addressing the chronic shortage of donor kidneys. “If an FDA-approved pig kidney were available, more than 70% of patients would consider it,” said Paul Conway of the American Association of Kidney Patients.