MiroliverELAP® for the Treatment of Acute Liver Failure: a Phase 1 Trial

Description

The clinical trail will assess the safety of miroliverELAP for the treatment of acute liver failure without underlying chronic liver disease. 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.

Conditions

Acute Liver Failure, Acute Liver Injury, Drug Induced

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Study Overview

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Study Details

Study overview

The clinical trail will assess the safety of miroliverELAP for the treatment of acute liver failure without underlying chronic liver disease. 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.

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

MiroliverELAP® for the Treatment of Acute Liver Failure: a Phase 1 Trial

Condition
Acute Liver Failure
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California San Francisco Medical Center, San Francisco, California, United States, 94143

Atlanta

Emory University School of Medicine, Atlanta, Georgia, United States, 30322

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Ann Arbor

University of Michigan Medical School, Ann Arbor, Michigan, United States, 48109

Minneapolis

University of Minnesota Medical School, Minneapolis, Minnesota, United States, 55455

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55902

New York

Mount Sinai Recanati/Miller Transplantation Institute, New York, New York, United States, 10029

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Salt Lake City

Intermountain Healthcare, Salt Lake City, Utah, United States, 84103

Richmond

Virginia Commonwealth University Medical Center, Richmond, Virginia, United States, 23970

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Miromatrix Medical Inc.,

Jack Lake, MD, STUDY_CHAIR, Miromatrix

Study Record Dates

2025-02-28