EGEN-5784 Porcine Liver With the Metra® ELC Device

Part of paid clinical trials in St Louis, Missouri.

Sponsor
eGenesis, INC
Study ID
NCT07429838
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx) — DEVICE
    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) — BIOLOGICAL
    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 Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Incidence of TESAE's [ Time Frame: From ELC initiation to 28 days post-ELC initiation ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Washington UniversitySt LouisMissouri63130
Jeffery Crippin MD
University of WisconsinMadisonWisconsin53792
David Foley, MD

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By research site
Washington University· St Louis, MOUniversity of Wisconsin· Madison, WI