Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT04657458
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-11-22
First Post:
2020-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS
Sponsor:
Direct Biologics, LLC
Organization:
Study Overview
Official Title:
Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment: Expanded Access Protocol for Patients With COVID-19 Associated ARDS
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2024-11
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:
ExoFlo, Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Allograft Product, Infusion Treatment is currently being studied in Protocol DB-EF-PhaseIII-0001 in patients COVID-19 associated moderate to severe acute respiratory distress syndrome (ARDS). This expanded access protocol is an open label study intended to provide ExoFlo to critically ill patients who do not qualify for the Phase III randomized controlled trial (RCT) because they
* Do not meet phase III eligibility criteria at current phase III sites.
* Do meet phase III eligibility criteria but cannot access phase III sites.
* Do not meet phase III eligibility criteria \& cannot access phase III sites.
* Do not meet phase III eligibility criteria at current phase III sites.
* Do meet phase III eligibility criteria but cannot access phase III sites.
* Do not meet phase III eligibility criteria \& cannot access phase III sites.
Detailed Description:
Objectives:
First, to provide Investigational Medicinal Product (IMP) to patients with COVID-19 associated moderate to severe ARDS who do not qualify for Protocol DB-EF-PHASEIII-0001. Secondarily, to collect safety and efficacy data.
Endpoints:
Primary Endpoint:
1\) 60-day All-Cause Mortality
Secondary Endpoints:
1. Incidence of serious adverse events (SAEs).
2. Ventilator-free days (VFDs).
3. Time to discharge.
Exploratory Endpoints:
1. Acute phase reactants: C-reactive protein (CRP), D-dimer, and Ferritin change from Baseline on Days 3, 5, 7, 10, 15, and 29 for subjects who are still hospitalized.
2. Sequential Organ Failure Assessment (SOFA) Score change from Baseline on Days 15, and 29 for subjects who are still hospitalized.
3. Improvement in partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) ratio from pre-infusion baseline (Day 0) to Day 7. PaO2 may be calculated from arterial blood gas (ABG) or imputed from the SpO2 daily.
Number of subjects: ≤200
Phase: Phase II /Expanded Access Protocol for Intermediate Population
First, to provide Investigational Medicinal Product (IMP) to patients with COVID-19 associated moderate to severe ARDS who do not qualify for Protocol DB-EF-PHASEIII-0001. Secondarily, to collect safety and efficacy data.
Endpoints:
Primary Endpoint:
1\) 60-day All-Cause Mortality
Secondary Endpoints:
1. Incidence of serious adverse events (SAEs).
2. Ventilator-free days (VFDs).
3. Time to discharge.
Exploratory Endpoints:
1. Acute phase reactants: C-reactive protein (CRP), D-dimer, and Ferritin change from Baseline on Days 3, 5, 7, 10, 15, and 29 for subjects who are still hospitalized.
2. Sequential Organ Failure Assessment (SOFA) Score change from Baseline on Days 15, and 29 for subjects who are still hospitalized.
3. Improvement in partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) ratio from pre-infusion baseline (Day 0) to Day 7. PaO2 may be calculated from arterial blood gas (ABG) or imputed from the SpO2 daily.
Number of subjects: ≤200
Phase: Phase II /Expanded Access Protocol for Intermediate Population
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: