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 : December 8, 2020
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. •
|Condition or disease||Intervention/treatment|
|Covid19 ARDS Hypoxia Cytokine Storm||Biological: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment|
|Study Type :||Expanded Access|
|Expanded Access Type :||Intermediate-size Population|
|Official Title:||Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment: Expanded Access Protocol for Patients With COVID-19 Associated ARDS Who Do Not Qualify for Phase II Randomized Control Trial|
- Biological: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment
Intravenous Infusion over 60 minutesOther Name: ExoFlo
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657458
|Contact: Heidi Moranemail@example.com|