Ignite Creation Date:
2024-05-06 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05116761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2021-11-09
Brief Title:
ExoFlo Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome
Sponsor:
Direct Biologics LLC
Organization:
Direct Biologics LLC
Study Overview
Official Title:
Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Post-Acute and Chronic Post-COVID-19 Syndrome A Phase III Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
This is a Phase III trial to evaluate the safety and efficacy of intravenous IV administration of bone marrow mesenchymal stem cell derived extracellular vesicles EV ExoFlo as treatment for Post-Acute COVID-19 and Chronic Post-COVID-19 syndrome
Detailed Description:
To evaluate the safety and efficacy of intravenous IV administration of bone marrow mesenchymal stem cell derived extracellular vesicles EV ExoFlo as treatment for Post-Acute COVID-19 and Chronic Post-COVID-19 syndrome
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