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

Status Not yet recruiting

Clinical Trial Summary

The clinical trail will assess the safety of miroliverELAP for the treatment of acute liver failure without underlying chronic liver disease. 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.

Clinical Trial Description

This is a phase 1, open, single arm safety study of miroliverELAP for the treatment of acute liver failure (ALF). Subjects who present with ALF and no underlying chronic liver disease 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. 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06285253
Study type	Interventional
Source	Miromatrix Medical Inc.
Contact	Joshua Carlson
Phone	612-670-5981
Email	jcarlson@miromatrix.com
Status	Not yet recruiting
Phase	Phase 1
Start date	May 1, 2024
Completion date	February 28, 2025

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05491135` - Hepatocyte Microbeads for Acute Liver Failure	Phase 1/Phase 2
Terminated	`NCT01937130` - Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF	Phase 2
Withdrawn	`NCT05940610` - The Safety and Efficacy of MSC-EVs in Acute/Acute-on-Chronic Liver Failure	Phase 1/Phase 2
Not yet recruiting	`NCT02833064` - Biomarkers in Liver Failure	N/A
Terminated	`NCT01875874` - Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF)	Phase 2
Not yet recruiting	`NCT01435421` - Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery	N/A
Completed	`NCT00245310` - Indocyangreen Elimination in Cirrhosis and Acute Liver Failure	N/A
Withdrawn	`NCT03629015` - Safety Study of Stemchymal® in Acute Liver Failure	Phase 1
Recruiting	`NCT04621812` - Role of Fecal Microbiota in Predicting Graft Rejection and Sepsis Among Recipients of Living Donor Liver Transplant in First Year.
Recruiting	`NCT03882346` - Study to Evaluate Safety and Efficacy of LifeLiver in Acute or Acute-on-Chronic Liver Failure Patients	Phase 2
Recruiting	`NCT05689645` - F573 for Injection for the Treatment of Liver Injury/Failure	Phase 2
Not yet recruiting	`NCT05772585` - Characterization of Metabolomic Fingerprints in Patients With Acute Liver Failure and Acute-on-chronic Liver Failure With Hepatic Encephalopathy
Completed	`NCT00655304` - The Effect of Prometheus (R) Liver Support Dialysis on Cerebral Metabolism in Acute Liver Failure	N/A
Completed	`NCT00059267` - Prevention of Recurrent Hepatitis B After Liver Transplantation	N/A
Active, not recruiting	`NCT05413083` - Evaluation of Cardiac Function in Acutely Decompensated Cirrhosis
Recruiting	`NCT05146336` - CytOSorb TreatMent Of Critically Ill PatientS Registry
Withdrawn	`NCT04089969` - Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct	N/A
Completed	`NCT02460510` - Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF	N/A
Completed	`NCT01872767` - Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure	N/A
Recruiting	`NCT01690845` - Molecular Adsorbent Recirculating System (MARS®) in Hypoxic Hepatitis	Phase 2