miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial

NCT06285253 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: MIRO-01-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 8

Brief Summary

The clinical trial will assess the safety of miroliverELAP for the treatment of acute liver failure, severe acute alcohol-associated hepatitis, or acute on chronic liver failure. miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver graft and an extracorporeal blood circuit. miroliverELAP Is intended to support the native (failed) liver for up to 48-hours of continuous treatment to allow time for liver recovery or to identify a transplantable liver.

Conditions

Acute Liver Failure; Acute Liver Injury, Drug Induced; Acute on Chronic Liver Failure (ACLF); Acute Alcoholic Hepatitis

Keywords

Acute liver failure; Extracorporeal liver assist; Bioengineered liver

Outcome Measures

Primary Outcomes (2)

• Survival

  Survival over the duration of miroliverELAP treatment

  48 hours

• Adverse Events

  Serious adverse events attributable to miroliverELAP

  32 days

Secondary Outcomes (1)

• 21-day survival

  21 days

Study Arms (1)

miroliverELAP treatment

EXPERIMENTAL

48 hour treatment with miroliverELAP

Combination Product: miroliverELAP treatment

Interventions

miroliverELAP treatment COMBINATION_PRODUCT

Subject's blood will be perfused through a bioengineered liver graft via an extracorporeal blood circuit.

miroliverELAP treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years to 80 years old at the time of signing the informed consent
• Subject must:
• be deemed competent to consent by an independent qualified practitioner, or
• have consent given by a Legally Authorized Representative
• Subject should be in the intensive care unit
• Be diagnosed with 4.1. Acute Liver Failure defined as:
• INR ≥ 2.0, and
• Hepatic Encephalopathy Grade II-III (West Haven Criteria), and
• Less than 4 weeks (28 days) of disease duration 4.2. Severe Acute Alcohol-Associated Hepatitis as defined as:
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• Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
• Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
• INR ≥ 2.0, and
• No overt evidence of cirrhosis 4.3. Acute on Chronic Liver Failure:
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You may not qualify if:

• Grade IV West Haven Encephalopathy Criteria
• Previous liver transplant
• Currently requires chronic hemodialysis (CRRT or other forms of continuous renal replacement are allowed).
• Uncontrolled documented infection, hypotension, or refractory shock. This is defined as a need for a single vasopressor, or combination of vasopressors, that exceed a norepinephrine equivalent of 0.5 mcg/kg/min.
• Liver injury due to trauma
• Any current liver cancer
• Currently on medications with a narrow therapeutic index
• Platelet count \< 40,000 μL
• If the subject is intubated and has an acute lung injury
• Experiencing a bleeding event, defined as:
• Active gastrointestinal or other overt bleeding event, or
• Hemoglobin drop \> 3g/dL within the past 24 hours, or
• Received ≥ 3 units of red blood cell transfusion within the past 24 hours
• Female that is currently pregnant, planning to be pregnant, or currently breastfeeding
• Refusal to receive blood products

Sponsors & Collaborators

• Miromatrix Medical Inc.: lead

Study Sites (8)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Michigan Medical School

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota Medical School

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Mount Sinai Recanati/Miller Transplantation Institute

New York, New York, 10029, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Intermountain Healthcare

Salt Lake City, Utah, 84103, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23970, United States

Location

MeSH Terms

Conditions

Liver Failure, Acute; Chemical and Drug Induced Liver Injury; Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Study Officials

• Jack Lake, MD

  Miromatrix

  STUDY CHAIR

Study Design

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

Model Details: Single arm, open label, safety study

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 29, 2024
• Study Start: October 5, 2024
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)