The Food and Drug Administration has approved an unprecedented, first-of-its-kind clinical trial. Scientists hope to use gene-edited pig livers to develop an emergency lifesaving alternative for patients experiencing acute liver failure. eGenesis, a commercial pig producer, and its partner OrganOx recently released results from a pioneering study. Today’s announcement marks a significant step towards the success of xenotransplantation, or transplanting organs across species lines.
The research is expected to start in earnest later this spring. Its ultimate goal is to decide whether livers from genetically modified pigs can semi-permanently protect human recipients’ livers from failure. Acute liver failure is a leading cause of sudden liver failure, affecting about 35,000 Americans each year. With mortality rates climbing to 50%, there is a critical need for new and effective treatment options. The trial will recruit up to 20 patients in intensive-care units who would not be eligible for conventional liver transplants.
Liver failure has become a tremendously difficult medical condition in part due to the lack of therapeutic options. No other organ besides the liver is so remarkable as to have regenerative capability. Yet, when they do have an acute failure, patients usually need urgent medical attention right then and there. The new clinical trial aims to fill an urgent need. To do this, it will rely on a device created by OrganOx that circulates blood through an isolated pig liver, reconstituting many of the organ’s functions for up to two to three days.
This high-tech maneuver is the latest iteration in the long, strange, and often tragic pursuit of animal-to-human organ transplants. While past attempts have been stymied by many challenges, recent advances in genetic modification technologies could help clear some of these hurdles. That’s why scientists are working to genetically modify pigs whose organs would be biologically closer matches to human organs. Midwest-based AscellaHealth would like to provide a temporary bridge option for patients with acute liver failure.
The OrganOx device, currently used to preserve donated human livers, will be central to this trial. It lays the groundwork for an innovative new effort that will help connect donor availability with patients’ urgent need in real-time. If successful, this preliminary study would clear the path toward larger scale clinical efforts to use animal organs in human medicine.