The FDA has cleared the first clinical trial to test genetically engineered pig livers in patients who have acute-on-chronic liver failure.
The trial will evaluate the use of a Egenesis porcine liver genetically modified to be more compatible with the human immune system in combination with the OrganOx extracorporeal liver cross-circulation system, according to an April 15 Egenesis news release.
The approach is intended for patients with acute-on-chronic liver failure who are in intensive care and experiencing decompensated liver function. Up to 20 patients with Grade 2 or 3 acute-on-chronic liver failure and hepatic encephalopathy who are not eligible for transplant will be enrolled at multiple U.S. sites.
Four uses of the porcine liver with the OrganOx system have been completed in decedent recipients as part of the Perfuse-2 study. The FDA clearance follows a November 2024 agreement between eGenesis and OrganOx to co-develop the approach for clinical use.
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