EGEN-5784 Porcine Liver With the Metra® ELC Device

May 5, 2026 updated by: eGenesis, INC

A Phase 1, First-in-Human Safety and Proof-of-Concept Study to Evaluate EGEN-5784 Porcine Liver (Drug Product) in Combination With the Metra® Extra-Corporeal Liver Cross-Circulation Device in Participants With Acute-on-Chronic Liver Failure

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

In Part 1, up to 6 participants will be enrolled and undergo ELC for up to 2 centers in the US.

In Part 2, up to 14 participants will be enrolled and undergo ELC at approximately 8 centers in the US.

The study will assess the safety of the ELC used to support liver function in patients with acute on chronic liver failure. Safety will be assessed based on Adverse Events Serious Adverse Events during the 28 days post-ELC and for the duration of the study. Unanticipated adverse device effects will be assessed during the ELC. Liver-related laboratory parameters will be assessed during the ELC treatment, and during the follow up period.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Washington University
        • Contact:
          • Jeffery Crippin MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin
        • Contact:
          • David Foley, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EGEN-5784 + metra® Extracorporeal Liver Cross-Circulation (ELC)
Participants with Grade 2-3 ACLF receive extracorporeal cross-circulation using a genetically engineered porcine liver (EGEN-5784) connected via the metra® ELC system, in addition to institutional standard of care. No comparator arm is included
Device: 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.
Other Names:
  • OrganOx metra
  • OrganOx ELC
  • ELC system
Biological: 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.
Other Names:
  • xenogeneic porcine liver
  • EGEN-5784 liver
  • Genetically Engineered Porcine Liver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of TESAE's
Time Frame: From ELC initiation to 28 days post-ELC initiation
Incidence of Treatment-Emergent Serious Adverse Event
From ELC initiation to 28 days post-ELC initiation
Incidence of AESIs
Time Frame: From ELC initiation through 28 days post ELC initation
Incidence of Adverse Event of Special Interest
From ELC initiation through 28 days post ELC initation
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)
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
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)
Incidence of Unanticipated Adverse Device Effect
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 Outcome Measures

Outcome Measure
Time Frame
Change in blood ammonia (NH₃), measured in µmol/L
Time Frame: From Baseline to 28 days post ELC initiation
From Baseline to 28 days post ELC initiation
Change in total bilirubin and direct bilirubin measured in mg/dL
Time Frame: From Baseline to 28 days post ELC initiation
From Baseline to 28 days post ELC initiation
Change in coagulation parameters, measured by international normalized ratio (INR)
Time Frame: From Baseline to 28 days post ELC initiation
From Baseline to 28 days post ELC initiation
Change in ACLF score
Time Frame: From Baseline to 28 days post ELC initiation
From Baseline to 28 days post ELC initiation
Change in West Haven criteria for hepatic encephalopathy
Time Frame: Baseline to 28 days post ELC initiation
Baseline to 28 days post ELC initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

eGenesis, INC

Collaborators

OrganOx Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGEN-5784-CL-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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