The U.S. Food and Drug Administration (FDA) has approved pilot clinical trials of genetically modified pig livers for extracorporeal support in acute decompensated liver failure, according to a press release from OrganOx and eGenesis. The technology involves temporarily connecting the EGEN-5784 GM pig liver, developed by eGenesis, to the patient's bloodstream using the metra extracorporeal hepatic cross-circulation (ELC) system, developed by OrganOx. The organ, located outside the body, should partially take over the functions of the damaged liver, allowing doctors to compensate for its failure or wait for a donor organ for transplantation.
The technology's feasibility was demonstrated in a trial involving four brain-dead patients with liver failure as part of the PERFUSE-2 study. The FDA-approved Phase I trials are expected to enroll up to 20 patients with grade 2-3 acute decompensated liver failure and grade 3 or higher hepatic encephalopathy who are not eligible for organ transplantation. Shortly before this FDA decision, Chinese researchers reported a successful transplant of a porcine GM liver into a brain-dead patient—the organ functioned for 10 days and was then routinely removed. Two months earlier, the FDA approved pilot clinical trials of porcine GM kidneys for transplantation involving six patients.
