NCT06285253

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

A Phase 1 Prospective Study of the Miromatrix External Liver Assist Product (miroliverELAP®) for Liver Support in Adults With Acute Liver Failure.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Miromatrix Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	miroliverELAP treatment	Subject's blood will be perfused through a bioengineered liver graft via an extracorporeal blood circuit.

Timeline

• Start date: 2024-10-05
• Primary completion: 2026-01-22
• Completion: 2026-01-22
• First posted: 2024-02-29
• Last updated: 2026-03-06

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study