RENEW: Study of Porcine Liver Support in Participants With Acute-on-Chronic Liver Failure
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsoreGenesis, INC
About this trial
This is a Phase 1/2, 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 system are designed to support liver function during the treatment period
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx)
DevicePerfusion circuit/device enabling extracorporeal cross-circulation between the participant and the EGEN-5784 porcine liver. Planned support up to 72 h in Part 1 and up to 120 h in Part 2 if no safety/stopping criteria are met, with ICU-level monitoring and protocol-defined operating parameters.
EGEN-5784 (genetically engineered porcine liver)
Biological/VaccineViable porcine liver from a genetically engineered donor (EGEN-5784) used for temporary extracorporeal cross-circulation support. The liver is not implanted; it is perfused in a closed circuit with the participant under continuous monitoring and predefined stopping rules per protocol.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: EGEN-5784 + metra® Extracorporeal Liver Cross-Circulation (ELC)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of TESAE's
Incidence of Treatment-Emergent Serious Adverse Event
Time frame
From ELC initiation to 28 days post-ELC initiation2
Incidence of AESIs
Incidence of Adverse Event of Special Interest
Time frame
From ELC initiation through 28 days post ELC initation3
Incidence of Device Deficiencies
Time frame
From metra® initiation through metra® ELC termination (assessed continuously during the ELC procedure; up to 72 hours in Part 1 and 120 hours in Part 2)4
Incidence of UADEs
Incidence of Unanticipated Adverse Device Effect
Time frame
From metra® initiation through metra® ELC termination (assessed continuously during the ELC procedure; up to 72 hours in Part 1 and 120 hours in Part 2)Secondary outcomes
1
Change in blood ammonia (NH₃), measured in µmol/L
Time frame
From Baseline to 28 days post ELC initiation2
Change in total bilirubin and direct bilirubin measured in mg/dL
Time frame
From Baseline to 28 days post ELC initiation3
Change in coagulation parameters, measured by international normalized ratio (INR)
Time frame
From Baseline to 28 days post ELC initiation4
Change in ACLF score
Time frame
From Baseline to 28 days post ELC initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
eGenesis, INC
Lead sponsor
OrganOx Ltd.
Collaborator
Source ClinicalTrials.gov
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