EGEN-5784 Porcine Liver With the Metra® ELC Device
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsoreGenesis, INC
About this trial
This is a Phase 1, first-in-human (FIH) safety, proof-of-concept, two-part study of the genetically-engineered EGEN-5784 liver in combination with the metra® extra-corporeal liver cross-circulation (ELC) system in participants with Grade 2 to Grade 3 acute-on-chronic liver failure (ACLF) and hepatic encephalopathy Grade 1-3. The metra® device has been modified for the purposes of cross-circulation with an extra-corporeal porcine liver. The EGEN-5784 liver and metra® ELC device are designed to support liver function during the treatment period
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx)
- EGEN-5784 (genetically engineered porcine liver)
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
eGenesis, INC
Lead sponsor
OrganOx Ltd.
Collaborator
Source ClinicalTrials.gov