miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial
Completed · Phase 1
Conditions studied: Acute Liver Failure, Acute Liver Injury, Drug Induced, Acute on Chronic Liver Failure (ACLF), Acute Alcoholic Hepatitis
In brief
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.
Key facts
- Study ID
- NCT06285253
- Run by
- Miromatrix Medical Inc.
- People needed
- 10
- Starts
- 2024-10-05
- Expected to finish
- 2026-01-22
- Last updated by the study team
- 2026-03-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 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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- Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
- Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
- INR ≥ 2.0,
- Subject is not a candidate for liver transplant and will not become a candidate in the event of worsening conditions.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
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