metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx): Perfusion 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): Viable 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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 or IV disorder
* Active uncontrolled bleeding (i.e., any major blood loss requiring ≥2 units of pRBCs within the last 48 hours prior to screening)
* Any other health condition, including illicit drug use, that would preclude participation in the study in the judgement of the PI
Primary outcome measure(s)
Incidence of TESAE's — From ELC initiation to 28 days post-ELC initiation Incidence of Treatment-Emergent Serious Adverse Event
Incidence of AESIs — From ELC initiation through 28 days post ELC initation Incidence of Adverse Event of Special Interest
Incidence of Device Deficiencies — 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)
Incidence of UADEs — 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) Incidence of Unanticipated Adverse Device Effect
Trial sites (2)
Facility
City
Region
Status
Washington University
St Louis
Missouri
University of Wisconsin
Madison
Wisconsin
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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