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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
Sponsor:
Information provided by (Responsible Party):
Direct Biologics, LLC

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. •

Condition or disease Intervention/treatment
Covid19 ARDS Hypoxia Cytokine Storm Biological: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment

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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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment
    Intravenous Infusion over 60 minutes
    Other Name: ExoFlo

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Provision of informed consent by self or proxy.
  • Stated willingness to comply with study protocol.
  • Male or female of any age ≥ 18 years of age
  • May be pregnant unless the patient has one or more conditions listed under Exclusion Criteria #4.
  • Positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) SARS-CoV-2.
  • Moderate to severe ARDS as defined by timing within 1 week of known clinical insult or new or worsening respiratory symptoms, bilateral opacities not fully explained by effusions or lung collapse, and respiratory failure not fully explained by cardiac failure or fluid overload, and PaO2/FiO2 ≤ 200 mmHg.
  • Downtrending PaO2/FiO2 despite standard of care (SOC).
  • Acute presentation of hypoxic respiratory failure requiring noninvasive oxygen support OR mechanical ventilation (MV).
  • Agreement to use highly effective birth control contraception if of reproductive age and potential.

Exclusion Criteria:

  • Active malignancy requiring treatment within the last five years.
  • Eligibility for enrollment in Protocol DB-EF-PhaseII-001.
  • Patients who are not full code.
  • Pregnant patients with current or past history of eclampsia, preeclampsia, hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome during pregnancy.
  • New York Heart Association (NYHA) Functional Class III (symptoms present during ordinary activities) or IV Heart Failure (symptoms present at rest) or listed for heart transplant.
  • Chronic Kidney Disease (CKD) Stage IV (GFR 15-29 mL/min/1.73m2) and Stage V (GFR < 15 mL/min/1.73m2) or listed for kidney transplant.
  • Hepatic Impairment with Model for End-Stage Liver Disease (MELD) score ≥ 30 or listed for liver transplant.
  • Patients on Extracorporeal Membrane Oxygenation (ECMO).

Information from the National Library of Medicine

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


Contacts
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Contact: Heidi Moran 800-791-1021 hmoran@directbiologics.com

Sponsors and Collaborators
Direct Biologics, LLC
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Responsible Party: Direct Biologics, LLC
ClinicalTrials.gov Identifier: NCT04657458    
Other Study ID Numbers: DB-EAP-001
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Keywords provided by Direct Biologics, LLC:
COVID-19
ARDS
SARS-CoV-2
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory