Ignite Creation Date:
2024-05-06 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05354141
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2022-04-27
Brief Title:
Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome ARDS EXTINGUISH ARDS
Sponsor:
Direct Biologics LLC
Organization:
Direct Biologics LLC
Study Overview
Official Title:
Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles for Hospitalized Patients With Moderate-to-Severe ARDS A Phase III Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04657458
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
To evaluate the safety and efficacy of intravenous IV administration of bone marrow mesenchymal stem cell derived extracellular vesicles EVs ExoFlo versus placebo for the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome ARDS
Detailed Description:
This is a Phase III multicenter randomized double-blinded placebo-controlled trial for the treatment of moderate-to-severe Acute Respiratory Distress Syndrome ARDS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None