Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT06340269
Status:
RECRUITING
Last Update Posted:
2025-05-08
First Post:
2024-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF
Sponsor:
Mexbrain
Organization:
Study Overview
Official Title:
Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in Acute on Chronic Liver Failure (ACLF)
Status:
RECRUITING
Status Verified Date:
2025-05
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:
MexACLF
Brief Summary:
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are:
* Is the device safe when used according to the instructions for use?
* Does the device work as expected by removing the excess of free iron from the blood?
Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week.
* Is the device safe when used according to the instructions for use?
* Does the device work as expected by removing the excess of free iron from the blood?
Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week.
Detailed Description:
This study investigates the safety and performance of the MEX-CD1 slow low volume CVVHD device in patients suffering from ACLF.
Acute-on-chronic liver failure (ACLF) is defined as a syndrome in patients with acutely decompensated cirrhosis, associated with single or multiple organ failures, and characterized by a high short-term mortality. ACLF is frequently triggered by a precipitating event (alcoholic hepatitis, infection, gastrointestinal haemorrhage) and characterized by an intense systemic inflammatory response driven per pathogen-associated molecular patterns (PAMPs) and/or damage-associated molecular patterns (DAMPs) responsible of the development of organs failure through tissues hypoperfusion, immune-mediated tissue damages and mitochondrial dysfunction.
Very importantly, ACLF is a very dynamic syndrome that has potential for reversibility. It is hypothesized that the extraction of non-transferrin bound iron (NTBI) could break down the vicious cycle of the excessive inflammatory responses, reduce oxidative stress and inhibit pathogen proliferation in ACLF patients.
As a consequence, it is hypothesized that the extraction of NTBI could promote improvement of ACLF grade n to ACLF grade n-1 or no ACLF. It is hypothesized that the extraction of NTBI could stop the progression of ACLF by preventing further organ failures and by reducing bacterial infection. Thereby, the extraction of NTBI could restore the eligibility of ACLF patients to liver transplantation, and, with or without liver transplantation, allow an earlier discharge from intensive care and prolong survival.
The proposed medical device, by combining dialysis to a hyper-chelating colloidal dialysate (MEX-CD1), specifically extracts free iron from the blood.
All patients enrolled in this study will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week. The duration of each MEX-CD1 Slow Low volume CVVHD session is 3h20.
Acute-on-chronic liver failure (ACLF) is defined as a syndrome in patients with acutely decompensated cirrhosis, associated with single or multiple organ failures, and characterized by a high short-term mortality. ACLF is frequently triggered by a precipitating event (alcoholic hepatitis, infection, gastrointestinal haemorrhage) and characterized by an intense systemic inflammatory response driven per pathogen-associated molecular patterns (PAMPs) and/or damage-associated molecular patterns (DAMPs) responsible of the development of organs failure through tissues hypoperfusion, immune-mediated tissue damages and mitochondrial dysfunction.
Very importantly, ACLF is a very dynamic syndrome that has potential for reversibility. It is hypothesized that the extraction of non-transferrin bound iron (NTBI) could break down the vicious cycle of the excessive inflammatory responses, reduce oxidative stress and inhibit pathogen proliferation in ACLF patients.
As a consequence, it is hypothesized that the extraction of NTBI could promote improvement of ACLF grade n to ACLF grade n-1 or no ACLF. It is hypothesized that the extraction of NTBI could stop the progression of ACLF by preventing further organ failures and by reducing bacterial infection. Thereby, the extraction of NTBI could restore the eligibility of ACLF patients to liver transplantation, and, with or without liver transplantation, allow an earlier discharge from intensive care and prolong survival.
The proposed medical device, by combining dialysis to a hyper-chelating colloidal dialysate (MEX-CD1), specifically extracts free iron from the blood.
All patients enrolled in this study will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week. The duration of each MEX-CD1 Slow Low volume CVVHD session is 3h20.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: