EGEN-5784 Porcine Liver With the Metra® ELC Device

Key Inclusion Criteria: * Male or female, age 18 to 70 years, inclusive * Not eligible for transplantation at the time of enrollment * Diagnosis of Grade 2 to 3 ACLF according to the European Association for the Study of Chronic Liver Failure (EASL-CLIF) definition and Chronic Liver Failure Consortium-organ failure score (CLIF-C-OF) ≥10 * Hepatic encephalopathy Grade 1 to 3 by West Haven Criteria * Written consent provided by participant or LAR (if participant lacks capacity, e.g., due to hepatic encephalopathy) prior to conduct of any study procedures Key Exclusion Criteria: * Prior solid organ transplant * Fulminant hepatic failure without underlying liver disease * Non-biological artificial liver extracorporeal liver support (e.g., molecular adsorbent recirculating system) or bioartificial liver support systems within 30 days prior to EGEN-5784 liver perfusion * Liver dysfunction due to trauma, or extra-hepatic cholestasis * Any uncontrolled ongoing active infection * History or active human immunodeficiency virus (HIV) infection or acute hepatitis B virus (HBV) * Chronic HBV or active hepatitis C * Diagnosis of cancer requiring active ongoing treatment, e.g., chemotherapy, radiation therapy * Severe concomitant cardiovascular disease defined as congestive heart failure Class III and IV * Significant acute or chronic pulmonary disease requiring ventilator support or diagnosed with chronic obstructive pulmonary disease Global Obstructive Lung Disease \[GOLD\] stage III o…