Acute Liver FailurePhase 1NCT06285253
miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial
A Phase 1 study testing miroliverELAP treatment in people with Acute Liver Failure and Acute Liver Injury, Drug Induced, run by Miromatrix Medical Inc. at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Liver Failure, Acute Liver Injury, Drug Induced, Acute on Chronic Liver Failure (ACLF)
- What is being tested?
- miroliverELAP treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 8 sitesUnited States
- Study dates
- 5 Oct 2024to 22 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years to 80 years old at the time of signing the informed consent
- Subject must:
- be deemed competent to consent by an independent qualified practitioner, or
- have consent given by a Legally Authorized Representative
- Subject should be in the intensive care unit
- Be diagnosed with 4.1. Acute Liver Failure defined as:
Show all 19Show fewer
- INR ≥ 2.0, and
- Hepatic Encephalopathy Grade II-III (West Haven Criteria), and
- Less than 4 weeks (28 days) of disease duration 4.2. Severe Acute Alcohol-Associated Hepatitis as defined as:
- <!-- -->
- Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
- Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
- INR ≥ 2.0, and
- No overt evidence of cirrhosis 4.3. Acute on Chronic Liver Failure:
- <!-- -->
- Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
- Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
- INR ≥ 2.0,
- 5. Subject is not a candidate for liver transplant and will not become a candidate in the event of worsening conditions.
Who cannot join
- Grade IV West Haven Encephalopathy Criteria
- Previous liver transplant
- Currently requires chronic hemodialysis (CRRT or other forms of continuous renal replacement are allowed).
- 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.
- Liver injury due to trauma
- Any current liver cancer
Show all 15Show fewer
- Currently on medications with a narrow therapeutic index
- Platelet count < 40,000 μL
- If the subject is intubated and has an acute lung injury
- Experiencing a bleeding event, defined as:
- Active gastrointestinal or other overt bleeding event, or
- Hemoglobin drop > 3g/dL within the past 24 hours, or
- Received ≥ 3 units of red blood cell transfusion within the past 24 hours
- Female that is currently pregnant, planning to be pregnant, or currently breastfeeding
- Refusal to receive blood products
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan Medical School
Ann Arbor, Michigan, 48109
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
Mount Sinai Recanati/Miller Transplantation Institute
New York, New York, 10029
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23970
Mayo Clinic
Rochester, Minnesota, 55902
Intermountain Healthcare
Salt Lake City, Utah, 84103
About this study
Official title: A Phase 1 Prospective Study of the Miromatrix External Liver Assist Product (miroliverELAP®) for Liver Support in Adults With Acute Liver Failure.
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.
Read the detailed description
This is a phase 1, open, single arm safety study of miroliverELAP for the treatment of acute liver failure (ALF), severe acute alcohol-associated hepatitis, or acute on chronic liver failure . Subjects who present with ALF, severe acute alcohol-associated hepatitis, or acute on chronic liver failure 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, severe acute alcohol-associated hepatitis, or acute on chronic liver failure. 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.
- Conditions
- Acute Liver Failure, Acute Liver Injury, Drug Induced, Acute on Chronic Liver Failure (ACLF), Acute Alcoholic Hepatitis
- Being tested
- miroliverELAP treatment
- Keywords
- Acute liver failure, Extracorporeal liver assist, Bioengineered liver
- Medical subject headings
- Liver Failure, Acute, Chemical and Drug Induced Liver Injury, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miroliverELAP treatmentCombination product
Subject's blood will be perfused through a bioengineered liver graft via an extracorporeal blood circuit.
| Study group | Role | What they receive |
|---|---|---|
| miroliverELAP treatment | Experimental | 48 hour treatment with miroliverELAP Receives: Combination Product: miroliverELAP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival over the duration of miroliverELAP treatment
Measured: 48 hours
Adverse Events
Serious adverse events attributable to miroliverELAP
Measured: 32 days
Secondary outcomes (1)
21-day survival
Survival for 21-days post initiation of miroliverELAP therapy
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start5 Oct 2024
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open label, safety study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miromatrix Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jack Lake, MD, Study chair, Miromatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285253
- Sponsor's protocol ID
- MIRO-01-001
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Prospective Study of the Miromatrix External Liver Assist Product (miroliverELAP®) for Liver Support in Adults With Acute Liver Failure.
- ClinicalTrials.gov ID
- NCT06285253
- Acronym / sponsor ID
- MIRO-01-001
- Conditions
- Acute Liver Failure, Acute Liver Injury, Drug Induced, Acute on Chronic Liver Failure (ACLF), Acute Alcoholic Hepatitis
- Keywords
- Acute liver failure, Extracorporeal liver assist, Bioengineered liver
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Miromatrix Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2024 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 1, open, single arm safety study of miroliverELAP for the treatment of acute liver failure (ALF), severe acute alcohol-associated hepatitis, or acute on chronic liver failure . Subjects who present with ALF, severe acute alcohol-associated hepatitis, or acute on chronic liver failure 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, severe acute alcohol-associated hepatitis, or acute on chronic liver failure. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open label, safety study
| Arm | Type | Receives |
|---|---|---|
| miroliverELAP treatment | Experimental | Combination Product: miroliverELAP treatment48 hour treatment with miroliverELAP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 18 years to 80 years old at the time of signing the informed consent
- Subject must:
- Subject should be in the intensive care unit
- Be diagnosed with 4.1. Acute Liver Failure defined as:
- <!-- -->
Key exclusion criteria (15 listed)
- Grade IV West Haven Encephalopathy Criteria
- Previous liver transplant
- Currently requires chronic hemodialysis (CRRT or other forms of continuous renal replacement are allowed).
- 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.
- Liver injury due to trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miroliverELAP treatmentSubject's blood will be perfused through a bioengineered liver graft via an extracorporeal blood circuit. | Combination product | miroliverELAP treatment |
Primary outcome
Survival
Time frame: 48 hours
Survival over the duration of miroliverELAP treatment
Adverse Events
Time frame: 32 days
Serious adverse events attributable to miroliverELAP
1 secondary outcome
21-day survival
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack Lake, MD study chair
Miromatrix
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing miroliverELAP treatment in people with Acute Liver Failure and Acute Liver Injury, Drug Induced, run by Miromatrix Medical Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.