Clinical trial NCT06285253: miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial
Official title: A Phase 1 Prospective Study of the Miromatrix External Liver Assist Product (miroliverELAP®) for Liver Support in Adults With Acute Liver Failure.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Acute Liver Failure
Acute Liver Injury, Drug Induced
Keywords: Acute liver failure
Extracorporeal liver assist
Bioengineered liver
Lead sponsor: Miromatrix Medical Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, open label, safety study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a phase 1, open, single arm safety study of miroliverELAP for the treatment of acute liver failure (ALF). Subjects who present with ALF and no underlying chronic liver disease may be eligible for the study. Subjects will be treated with miroliverELAP continuously for 48 hours. The study will assess the safety of the miroliverELAP used to support liver function in an individual experiencing ALF. Safety profile will be characterized by survival over the duration of therapy, tracking miroliverELAP-related adverse events, the proportion of subjects surviving 21-day post treatment initiation, and the difference in the values of specific biomarkers pre-treatment and at the time of treatment discontinuation; such as: albumin, ammonia, creatinine, INR, and lactate blood concentration. A minimum of 5 subjects will be treated for 48 hours and followed for 32 days. Up to 15 subjects may be enrolled in up to 8 study sites.

Eligibility criteria: 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

Primary outcomes:
measure: Survival
timeFrame: 48 hours
measure: Adverse Events
timeFrame: 32 days
Secondary outcomes:
measure: 21-day survival
timeFrame: 21 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan Medical School
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical School
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Mount Sinai Recanati/Miller Transplantation Institute
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Salt Lake City
country: United States
facility: Intermountain Healthcare
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Miromatrix
name: Jack Lake, MD
role: STUDY_CHAIR
References: