miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial
NCT ID: NCT06285253
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2024-10-05
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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miroliverELAP treatment
48 hour treatment with miroliverELAP
miroliverELAP treatment
Subject's blood will be perfused through a bioengineered liver graft via an extracorporeal blood circuit.
Interventions
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miroliverELAP treatment
Subject's blood will be perfused through a bioengineered liver graft via an extracorporeal blood circuit.
Eligibility Criteria
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Inclusion Criteria
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:
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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:
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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
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
18 Years
80 Years
ALL
No
Sponsors
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Miromatrix Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jack Lake, MD
Role: STUDY_CHAIR
Miromatrix
Locations
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Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Michigan Medical School
Ann Arbor, Michigan, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Mount Sinai Recanati/Miller Transplantation Institute
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Justin Boike, MD
Role: primary
Lena Napolitano, MD
Role: primary
Thomas Leventhal, MD
Role: primary
Jody Olson, MD
Role: primary
Sander Florman, MD
Role: primary
Aanchal Kapoor, MD
Role: primary
Christopher Danford, MD
Role: primary
Joel Wedd, MD
Role: primary
Other Identifiers
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MIRO-01-001
Identifier Type: -
Identifier Source: org_study_id
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