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A Global Expanded Access Protocol on Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Infusion Treatment for Patients With COVID-19 Associated ARDS

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ClinicalTrials.gov Identifier: NCT04657458
Expanded Access Status : Available
First Posted : December 8, 2020
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
Direct Biologics, LLC

Tracking Information
First Submitted Date December 7, 2020
First Posted Date December 8, 2020
Last Update Posted Date May 2, 2022
 
Descriptive Information
Brief Title A Global Expanded Access Protocol on Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Infusion Treatment for Patients With COVID-19 Associated ARDS
Brief Summary

Infusion Treatment Using Bone Marrow Mesenchymal Stem Cell (bmMSC) Derived Extracellular Vesicle Product, ExoFlo™, for COVID-19 Associated ARDS (EXIT COVID-19), is currently being studied in Protocol DB-EF-PhaseII-001 in patients with 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 II randomized controlled trial because they:

  • Do not meet phase II eligibility criteria at current phase II sites.
  • Do meet phase II eligibility criteria but cannot access phase II sites.
  • Do not meet phase II eligibility criteria & cannot access phase II sites. •
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Intermediate-size Population
Intervention Biological: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment
Intravenous Infusion over 60 minutes
Other Name: ExoFlo
Publications * Sengupta V, Sengupta S, Lazo A, Woods P, Nolan A, Bremer N. Exosomes Derived from Bone Marrow Mesenchymal Stem Cells as Treatment for Severe COVID-19. Stem Cells Dev. 2020 Jun 15;29(12):747-754. doi: 10.1089/scd.2020.0080. Epub 2020 May 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Heidi Moran 800-791-1021 hmoran@directbiologics.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04657458
Current Responsible Party Direct Biologics, LLC
Original Responsible Party Same as current
Current Study Sponsor Direct Biologics, LLC
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Direct Biologics, LLC
Verification Date April 2022