Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285253
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-02-21
Brief Title:
MiroliverELAP for the Treatment of Acute Liver Failure a Phase 1 Trial
Sponsor:
Miromatrix Medical Inc
Organization:
Miromatrix Medical Inc
Study Overview
Official Title:
A Phase 1 Prospective Study of the Miromatrix External Liver Assist Product miroliverELAP for Liver Support in Adults with Acute Liver Failure
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None