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Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for ARDS

NCT05127122 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2024-07-29

No results posted yet for this study

Summary

To evaluate the safety and efficacy of intravenous(IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles(EV), ExoFlo, as treatment for Acute Respiratory Distress Syndrome.

Conditions

  • ARDS, Human

Interventions

DRUG

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

Injectable

OTHER

Saline

Placebo Saline

Sponsors & Collaborators

  • Direct Biologics, LLC

    lead INDUSTRY

Principal Investigators

  • Bill Arana · Direct Biologics, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05127122 on ClinicalTrials.gov