RECRUITING

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

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Conditions

Acute Liver FailureAcute Liver Injury, Drug InducedAcute on Chronic Liver Failure (ACLF)Acute Alcoholic HepatitisExtracorporeal liver assistBioengineered liver

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-05
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06285253

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years to 80 years old at the time of signing the informed consent
  2. 2. Subject must:
  3. 1. be deemed competent to consent by an independent qualified practitioner, or
  4. 2. have consent given by a Legally Authorized Representative
  5. 3. Subject should be in the intensive care unit
  6. 4. Be diagnosed with 4.1. Acute Liver Failure defined as:
  7. 1. INR ≥ 2.0, and
  8. 2. Hepatic Encephalopathy Grade II-III (West Haven Criteria), and
  9. 3. Less than 4 weeks (28 days) of disease duration 4.2. Severe Acute Alcohol-Associated Hepatitis as defined as:
  10. 1. Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
  11. 2. Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
  12. 3. INR ≥ 2.0, and
  13. 4. No overt evidence of cirrhosis 4.3. Acute on Chronic Liver Failure:
  14. 1. Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
  15. 2. Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
  16. 3. INR ≥ 2.0,
  17. 1. Grade IV West Haven Encephalopathy Criteria
  18. 2. Previous liver transplant
  19. 3. Currently requires chronic hemodialysis (CRRT or other forms of continuous renal replacement are allowed).
  20. 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.
  21. 5. Liver injury due to trauma
  22. 6. Any current liver cancer
  23. 7. Currently on medications with a narrow therapeutic index
  24. 8. Platelet count \< 40,000 μL
  25. 9. If the subject is intubated and has an acute lung injury
  26. 10. Experiencing a bleeding event, defined as:
  27. 1. Active gastrointestinal or other overt bleeding event, or
  28. 2. Hemoglobin drop \> 3g/dL within the past 24 hours, or
  29. 3. Received ≥ 3 units of red blood cell transfusion within the past 24 hours
  30. 11. Female that is currently pregnant, planning to be pregnant, or currently breastfeeding
  31. 12. Refusal to receive blood products
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Joshua Carlson
CONTACT
612-670-5981
jcarlson@miromatrix.com
M. Mason Macenski, PhD
CONTACT
612-378-2612
mmacenski@miromatrix.com

Principal Investigator

Jack Lake, MD
STUDY_CHAIR
Miromatrix

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Miromatrix Medical Inc.

  • Jack Lake, MD, STUDY_CHAIR, Miromatrix

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-05
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-10-05
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Acute liver failure
  • Extracorporeal liver assist
  • Bioengineered liver

Additional Relevant MeSH Terms

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