NCT05116761

ExoFlo™ Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Post-Acute and Chronic Post-COVID-19 Syndrome: A Phase I/II Clinical Trial

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Direct Biologics, LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II 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.

Conditions

• Covid19
• Postviral Syndrome
• Dyspnea

Interventions

Type	Name	Description
BIOLOGICAL	Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles	Intravenous administration of Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles
OTHER	Saline	Placebo Saline

Timeline

• Start date: 2024-11-01
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2021-11-11
• Last updated: 2024-11-22

Regulatory

• FDA-regulated drug study