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 eGenesis-engineered pig liver EGEN-5784 to the patient’s bloodstream using OrganOx’s metra extracorporeal hepatic cross-circulation (ELC) system. The organ outside the body should partially take over the functions of the diseased liver to give doctors the opportunity to compensate for its failure or wait for a donor organ for transplantation.
The technology’s practical utility was demonstrated in an experiment with four patients with brain death and liver failure as part of the PERFUSE-2 study. The FDA-approved Phase I trials are 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 decision by the agency, Chinese researchers reported a successful transplant of a pig GM liver into a brain-dead patient — the organ functioned for 10 days and was routinely removed. Two months earlier, the FDA approved a pilot clinical trial of pig GM kidneys for transplantation involving six patients.