Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Alcoholic Hepatitis Acute Liver Failure Acute Liver Injury, Drug Induced Acute on Chronic Liver Failure (ACLF)

Keywords

Acute liver failureExtracorporeal liver assistBioengineered liver

Outcome Measures

Primary Outcomes (2)

Survival
Survival over the duration of miroliverELAP treatment
48 hours
Adverse Events
Serious adverse events attributable to miroliverELAP
32 days

Secondary Outcomes (1)

21-day survival
21 days

Study Arms (1)

miroliverELAP treatment

EXPERIMENTAL

48 hour treatment with miroliverELAP

Combination Product: miroliverELAP treatment

Interventions

miroliverELAP treatmentCombination product

Subject's blood will be perfused through a bioengineered liver graft via an extracorporeal blood circuit.

miroliverELAP treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years to 80 years old at the time of signing the informed consent
Subject must:

Sponsors & Collaborators

Miromatrix Medical Inc.
Industrylead

Study Sites (8)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

University of Michigan Medical School

Ann Arbor, Michigan, 48109, United States

University of Minnesota Medical School

Minneapolis, Minnesota, 55455, United States

Mayo Clinic

Rochester, Minnesota, 55902, United States

Mount Sinai Recanati/Miller Transplantation Institute

New York, New York, 10029, United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Intermountain Healthcare

Salt Lake City, Utah, 84103, United States

MeSH Terms

Conditions

Liver Failure, AcuteChemical and Drug Induced Liver InjuryAcute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Study Officials

Jack Lake, MD
Miromatrix
STUDY CHAIR

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 21, 2024

First Posted

February 29, 2024

Study Start

October 5, 2024

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

miroliverELAP treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

miroliverELAP treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations