FDA Approves Trial Using Pig Livers to Treat Human Liver Failure
Federal agency clears path for innovative medical research using gene-edited animals
The Food and Drug Administration has approved a groundbreaking clinical trial that will test whether gene-edited pig livers can help treat patients with acute liver failure. Rather than transplanting the organs, researchers will temporarily connect the pig livers externally to filter patients' blood, potentially allowing their own livers time to rest and regenerate. The trial represents a significant development in the federal government's oversight of xenotransplantation research.
The study, expected to begin this spring, will enroll up to 20 intensive care patients who don't qualify for traditional liver transplants. Massachusetts-based company eGenesis, which genetically modifies pigs to make their organs more compatible with humans, will provide the organs for the trial. A device manufactured by British company OrganOx will pump participants' blood through the pig liver, building on previous experiments with deceased bodies that showed the approach could support human liver functions for several days.
KEY POINTS
- •FDA approves pig liver treatment trial
- •External filtering instead of transplant
- •Targets 35,000 annual liver failure cases
This FDA-approved trial addresses a critical healthcare need in the United States, where approximately 35,000 people are hospitalized annually with sudden liver failure. Current treatment options are limited, with mortality rates reaching 50% for these patients. Many individuals either don't qualify for liver transplants or cannot receive matched organs quickly enough, highlighting the potential public health significance of this federally sanctioned research.
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