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

Acute Liver Failure Clinical 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06285253
• Other study ID #: MIRO-01-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 1, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Miromatrix Medical Inc.
• Contact: Joshua Carlson
• Phone: 612-670-5981
• Email: jcarlson[@]miromatrix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: February 28, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Liver Failure
• Acute Liver Injury, Drug Induced
• Chemical and Drug Induced Liver Injury
• Hepatic Insufficiency
• Liver Failure
• Liver Failure, Acute

Intervention

Combination Product:
• miroliverELAP treatment
Subject's blood will be perfused through a bioengineered liver graft via an extracorporeal blood circuit.

Locations

Country	Name	City	State
United States	University of Michigan Medical School	Ann Arbor	Michigan
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Minnesota Medical School	Minneapolis	Minnesota
United States	Mount Sinai Recanati/Miller Transplantation Institute	New York	New York
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Intermountain Healthcare	Salt Lake City	Utah
United States	University of California San Francisco Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Miromatrix Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival over the duration of miroliverELAP treatment	48 hours
Primary	Adverse Events	Serious adverse events attributable to miroliverELAP	32 days
Secondary	21-day survival	Survival for 21-days post initiation of miroliverELAP therapy	21 days