Using miroliverELAP to treat acute liver failure
A Phase 1 Prospective Study of the Miromatrix External Liver Assist Product (miroliverELAP®) for Liver Support in Adults With Acute Liver Failure.
This study is testing a new treatment using a special liver device to see if it can help people with acute liver failure recover or find out if they need a transplant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Miromatrix Medical Inc. Industry-sponsored |
| Locations | 8 sites (Chicago, Illinois and 7 other locations) |
| Trial ID | NCT06285253 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with acute liver failure and not eligible for liver transplantation.
Not a fit: Patients with underlying chronic liver disease or those who have previously undergone a liver transplant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a critical support mechanism for patients with acute liver failure, potentially improving survival rates and outcomes.
How similar studies have performed: While this approach is innovative, similar studies exploring bioengineered liver support systems have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 7 other locations
- 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)
- Intermountain Healthcare — Salt Lake City, Utah, United States (Recruiting)
- Virginia Commonwealth University Medical Center — Richmond, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Joshua Carlson
- Email: jcarlson@miromatrix.com
- Phone: 612-670-5981
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.