Using miroliverELAP to treat acute liver failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 clinical trial evaluates the safety of miroliverELAP, a bioengineered liver graft combined with an extracorporeal blood circuit, for patients experiencing acute liver failure without chronic liver disease. Participants will receive continuous treatment for 48 hours, during which the study will monitor survival rates, adverse events, and changes in specific biomarkers related to liver function. The trial aims to determine if this innovative approach can support liver recovery or identify candidates for transplantation. A minimum of 5 subjects will be treated, with follow-up assessments extending for 32 days post-treatment.

Why it matters

Who can join: the full rules

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. Be diagnosed with acute liver failure as defined as:

   1. INR ≥ 2.5, and
   2. Hepatic Encephalopathy Grade II-III (West Haven Criteria), and
   3. Less than 4 weeks (28 days) of disease duration
4. Subject is not a candidate for liver transplant and will not become a candidate in the event of worsening conditions.

Exclusion Criteria

1. Underlying chronic liver disease, including:

   1. Acute-on-chronic liver disease
   2. Acute alcoholic-associated hepatitis
   3. Cirrhosis
2. Grade IV West Haven Encephalopathy Criteria
3. Previous liver transplant
4. Currently requires chronic hemodialysis (CRRT or other forms of continuous renal replacement are allowed).
5. 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 0.3 mcg/kg/min.
6. Liver injury due to trauma
7. Any current liver cancer
8. Currently on medications with a narrow therapeutic index
9. Platelet count \< 40,000 μL
10. If the subject is intubated and has an acute lung injury
11. 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
12. Female that is currently pregnant, planning to be pregnant, or currently breastfeeding
13. Refusal to receive blood products

Where it's running

• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting
• University of Michigan Medical School
  Ann Arbor, Michigan, United States Recruiting
• University of Minnesota Medical School
  Minneapolis, Minnesota, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Mount Sinai Recanati/Miller Transplantation Institute
  New York, New York, United States Recruiting
• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Joshua Carlson
• Email: jcarlson@miromatrix.com
• Phone: 612-670-5981

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.