NCT07429838

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
17mo left

Started Jun 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Jun 2026Jan 2028

First Submitted

Initial submission to the registry

January 8, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

January 8, 2026

Last Update Submit

May 5, 2026

Conditions

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

Keywords

Extra-corporeal live cross-circulationMetra

Outcome Measures

Primary Outcomes (4)

  • Incidence of TESAE's

    Incidence of Treatment-Emergent Serious Adverse Event

    From ELC initiation to 28 days post-ELC initiation

  • Incidence of AESIs

    Incidence of Adverse Event of Special Interest

    From ELC initiation through 28 days post ELC initation

  • 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

    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 Outcomes (5)

  • Change in blood ammonia (NH₃), measured in µmol/L

    From Baseline to 28 days post ELC initiation

  • Change in total bilirubin and direct bilirubin measured in mg/dL

    From Baseline to 28 days post ELC initiation

  • Change in coagulation parameters, measured by international normalized ratio (INR)

    From Baseline to 28 days post ELC initiation

  • Change in ACLF score

    From Baseline to 28 days post ELC initiation

  • Change in West Haven criteria for hepatic encephalopathy

    Baseline to 28 days post ELC initiation

Study Arms (1)

EGEN-5784 + metra® Extracorporeal Liver Cross-Circulation (ELC)

EXPERIMENTAL

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)Biological: EGEN-5784 (genetically engineered porcine liver)

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.

Also known as: OrganOx metra, OrganOx ELC, ELC system
EGEN-5784 + metra® Extracorporeal Liver Cross-Circulation (ELC)
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.

Also known as: xenogeneic porcine liver, EGEN-5784 liver, Genetically Engineered Porcine Liver
EGEN-5784 + metra® Extracorporeal Liver Cross-Circulation (ELC)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Washington University

St Louis, Missouri, 63130, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver FailureHepatic Encephalopathy

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Central Study Contacts

Patient Inquires

CONTACT

617-941-7500PatientInfo@egenesisbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

February 24, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

May 7, 2026

Record last verified: 2026-05

Locations

US(2)