MedTrace Logo

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

NCT06285253 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-06

No results posted yet for this study

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. 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.

Conditions

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

Interventions

COMBINATION_PRODUCT

miroliverELAP treatment

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

Sponsors & Collaborators

  • Miromatrix Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Jack Lake, MD · Miromatrix

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-05
Primary Completion
2026-01-22
Completion
2026-01-22
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06285253 on ClinicalTrials.gov