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

A Phase 1 Prospective Study of the Miromatrix External Liver Assist Product (miroliverELAP®) for Liver Support in Adults With Acute Liver Failure.

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.

Study Overview

• Status: Completed
• Conditions: Acute Liver Failure; Acute Alcoholic Hepatitis; Acute Liver Injury, Drug Induced; Acute on Chronic Liver Failure (ACLF)
• Intervention / Treatment: Combination product: miroliverELAP treatment

Detailed Description

This is a phase 1, open, single arm safety study of miroliverELAP for the treatment of acute liver failure (ALF), severe acute alcohol-associated hepatitis, or acute on chronic liver failure . Subjects who present with ALF, severe acute alcohol-associated hepatitis, or acute on chronic liver failure may be eligible for the study. Subjects will be treated with miroliverELAP continuously for 48 hours. The study will assess the safety of the miroliverELAP used to support liver function in an individual experiencing ALF, severe acute alcohol-associated hepatitis, or acute on chronic liver failure. Safety profile will be characterized by survival over the duration of therapy, tracking miroliverELAP-related adverse events, the proportion of subjects surviving 21-day post treatment initiation, and the difference in the values of specific biomarkers pre-treatment and at the time of treatment discontinuation; such as: albumin, ammonia, creatinine, INR, and lactate blood concentration. A minimum of 5 subjects will be treated for 48 hours and followed for 32 days. Up to 15 subjects may be enrolled in up to 8 study sites.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Medical School
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical School
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Recanati/Miller Transplantation Institute
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Utah
    • Salt Lake City, Utah, United States, 84103
      • Intermountain Healthcare
  • Virginia
    • Richmond, Virginia, United States, 23970
      • Virginia Commonwealth University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years to 80 years old at the time of signing the informed consent

2. Subject must:

   1. be deemed competent to consent by an independent qualified practitioner, or
   2. have consent given by a Legally Authorized Representative
3. Subject should be in the intensive care unit

4. Be diagnosed with 4.1. Acute Liver Failure defined as:

   1. INR ≥ 2.0, and
   2. Hepatic Encephalopathy Grade II-III (West Haven Criteria), and
   3. Less than 4 weeks (28 days) of disease duration 4.2. Severe Acute Alcohol-Associated Hepatitis as defined as:
   1. Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
   2. Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
   3. INR ≥ 2.0, and
   4. No overt evidence of cirrhosis 4.3. Acute on Chronic Liver Failure:
   1. Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
   2. Model for End-Stage Liver Disease (MELD) Score ≥ 20, and

   3. INR ≥ 2.0,

      5. Subject is not a candidate for liver transplant and will not become a candidate in the event of worsening conditions.

Exclusion Criteria

1. Grade IV West Haven Encephalopathy Criteria
2. Previous liver transplant
3. Currently requires chronic hemodialysis (CRRT or other forms of continuous renal replacement are allowed).
4. 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.
5. Liver injury due to trauma
6. Any current liver cancer
7. Currently on medications with a narrow therapeutic index
8. Platelet count < 40,000 μL
9. If the subject is intubated and has an acute lung injury

10. Experiencing a bleeding event, defined as:

    1. Active gastrointestinal or other overt bleeding event, or
    2. Hemoglobin drop > 3g/dL within the past 24 hours, or
    3. Received ≥ 3 units of red blood cell transfusion within the past 24 hours
11. Female that is currently pregnant, planning to be pregnant, or currently breastfeeding
12. Refusal to receive blood products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: miroliverELAP treatment; 48 hour treatment with miroliverELAP	Combination product: miroliverELAP treatment; Subject's blood will be perfused through a bioengineered liver graft via an extracorporeal blood circuit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Survival over the duration of miroliverELAP treatment	48 hours
Adverse Events	Serious adverse events attributable to miroliverELAP	32 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
21-day survival	Survival for 21-days post initiation of miroliverELAP therapy	21 days

Collaborators and Investigators

• Sponsor: Miromatrix Medical Inc.
• Investigators: Study Chair: Jack Lake, MD, Miromatrix

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2024
• Primary Completion (Actual): January 22, 2026
• Study Completion (Actual): January 22, 2026

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Acute liver failure; Extracorporeal liver assist; Bioengineered liver
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Poisoning; Liver Failure; Hepatic Insufficiency; Liver Failure, Acute; Acute-On-Chronic Liver Failure; Chemical and Drug Induced Liver Injury
• Other Study ID Numbers: MIRO-01-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No