NCT05125562

Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19: A Phase II Clinical Trial

• Status: Withdrawn
• Phase: 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

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	ExoFlo	Patients will be randomized to one of three infusions: (1) Normal Saline 100 mL, (2) Normal saline 90 mL and ExoFlo 10 mL, which is 7x1011 EVs, and (3) Normal saline 85 mL and ExoFlo 15 mL, which is 10.5x1011 EVs. The study intervention will only be dosed on day=1

Timeline

• Start date: 2022-12-07
• Primary completion: 2023-03-07
• Completion: 2023-03-07
• First posted: 2021-11-18
• Last updated: 2024-02-13

Regulatory

• FDA-regulated drug study