A Phase 1/2 interventional study of metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx) and EGEN-5784 (genetically engineered porcine liver) in Acute on Chronic Liver Failure (ACLF) and Hepatic Encephalopathy (HE), sponsored by eGenesis, INC. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by eGenesis, INC · Phase 1/2, Interventional, and Treatment
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
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
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.
165 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 60 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 95 interventional studies indexed under Acute-On-Chronic Liver Failure.
Browse Acute-On-Chronic Liver Failure studies →This is the only study on the registry with eGenesis, INC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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
Incidence of TESAE's
Incidence of Treatment-Emergent Serious Adverse Event
Time frame: From ELC initiation to 28 days post-ELC initiation
Incidence of AESIs
Incidence of Adverse Event of Special Interest
Time frame: 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)
Incidence of UADEs
Incidence of Unanticipated Adverse Device Effect
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)
Change in blood ammonia (NH₃), measured in µmol/L
Time frame: 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
Change in coagulation parameters, measured by international normalized ratio (INR)
Time frame: From Baseline to 28 days post ELC initiation
Change in ACLF score
Time frame: 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
Plan to share: Undecided
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Acute-On-Chronic Liver Failure →