MedTrace Logo

Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS

NCT04657458 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2024-11-22

No results posted yet for this study

Summary

ExoFlo, Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Allograft Product, Infusion Treatment is currently being studied in Protocol DB-EF-PhaseIII-0001 in patients COVID-19 associated moderate to severe acute respiratory distress syndrome (ARDS). This expanded access protocol is an open label study intended to provide ExoFlo to critically ill patients who do not qualify for the Phase III randomized controlled trial (RCT) because they

* Do not meet phase III eligibility criteria at current phase III sites.
* Do meet phase III eligibility criteria but cannot access phase III sites.
* Do not meet phase III eligibility criteria \& cannot access phase III sites.

Conditions

  • Covid19
  • ARDS
  • Hypoxia
  • Cytokine Storm

Interventions

BIOLOGICAL

ExoFlo

Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

Sponsors & Collaborators

  • Direct Biologics, LLC

    lead INDUSTRY

Principal Investigators

  • Bill Arana · Direct Biologics, LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

More Related Trials

Entities

Diseases

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 NCT04657458 on ClinicalTrials.gov