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EGEN-5784 Porcine Liver With the Metra® ELC Device

NCT07429838 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-07

No results posted yet for this study

Summary

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

Conditions

  • Acute on Chronic Liver Failure (ACLF)
  • Hepatic Encephalopathy (HE)

Interventions

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.

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.

Sponsors & Collaborators

  • OrganOx Ltd.

    collaborator INDUSTRY

  • eGenesis, INC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2028-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07429838 on ClinicalTrials.gov