April 16, 2025
The FDA’s clearance of EGEN-5784 in combination with the OrganOx ELC system represents a significant advance towards fulfilling our mission to develop safe and effective human-compatible organs that have the potential to transform the treatment of organ failure and extend patients’ lives.
CEO of pharmaceutical company eGenesis, Michael Curtis, after the U.S. Food and Drug Administration (FDA) cleared a trial that will test whether livers from a gene-edited pig could help treat patients with sudden liver failure.
Why It Matters: According to the news release, approximately 35,000 people end up hospitalized for liver failure each year in the U.S. and, as limited treatment options exist, death rates can be as high as 50% since many people are ineligible for transplants or cannot find a match. The FDA’s green-light of the new study marks the first-of-its-kind trial.
- In the trial, researchers will not transplant the pig liver but rather will attach it externally to up to 20 study participants who are ineligible for transplants. The aim is to see if the pig’s liver can filter human blood for a short time, giving the patient’s liver a chance to heal.
- The study will be led by eGenesis, a Massachusetts-based company that genetically modifies organs to make them more compatible with humans. eGenesis will use a device made by British company OrganOx to help facilitate the temporary use of the pig liver with patients.
- The new study will likely begin later this spring.
Read More: FDA OKs trial of pig livers as dialysis-like treatment for liver failure (ABC News)
Photo Credit: FDA clears eGenesis’ genetically engineered porcine liver for Phase I trial (Clinical Trials Arena)
by Emily Hooker, based in Texas
