Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05125562
Status:
WITHDRAWN
Last Update Posted:
2024-02-13
First Post:
2021-11-11
Brief Title:
Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19
Sponsor:
Direct Biologics LLC
Organization:
Direct Biologics LLC
Study Overview
Official Title:
Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19 A Phase II Clinical Trial
Status:
WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor has withdrawnclosed the IND with the FDA A letter dated 21NOV2022 was submitted to the FDA
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04657458
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
Early Mild Outpatient infusion Therapy with ExoFloTM for COVID-19 EMOTE COVID-19
To evaluate the safety and efficacy of intravenous IV administration of bone marrow mesenchymal stem cell derived extracellular vesicles ExoFlo as treatment for mild-moderate COVID-19
To evaluate the safety and efficacy of intravenous IV administration of bone marrow mesenchymal stem cell derived extracellular vesicles ExoFlo as treatment for mild-moderate COVID-19
Detailed Description:
None
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