Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04657458
Expanded Access Status : Available
First Posted : December 8, 2020
Last Update Posted : July 12, 2021
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

Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Provision of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Male or female of any age ≥ 18 years of age.
  4. May be pregnant unless patient has one or more conditions listed in Exclusion Criteria #4.
  5. COVID-19 positive as defined by positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) SARS-CoV-2.
  6. Moderate to severe ARDS as defined by modified Berlin definition (see Table 3), which includes timing within 1 week of known clinical insult or new or worsening respiratory symptoms; bilateral opacities not fully explained by effusions, or lung collapse; respiratory failure not fully explained by cardiac failure or fluid overload; PaO2/FiO2 ≤200 mm Hg.
  7. Acute presentation of hypoxia requiring noninvasive oxygen support such as NC, NRB, bilevel positive airway pressure, HFNC. OR Acute presentation of hypoxic respiratory failure which required intubation and subsequent MV.
  8. If the candidate is either male or female of reproductive potential, he or she must agree to use of double barrier method of highly effective birth control contraception such as condoms with oral contraceptive pill or choose to remain abstinent if already practicing abstinence during the screening period. The duration of required usage of double barrier method OR maintenance of abstinence must include the time from the beginning of the screening period until 90 days following the last dose of the study treatment.

    • Standard of care is defined as the clinical practices that are consistent with the NIH updated guidelines for COVID-19

Exclusion from study enrollment includes meeting one or more of the following criteria:

  1. Active malignancy requiring treatment within the last five years.
  2. Eligibility for enrollment in Protocol DB-EF-PhaseII-001.
  3. Patients who are not full code.
  4. Pregnant patients with current or past history of eclampsia, preeclampsia, hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome during pregnancy.
  5. 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.
  6. 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.
  7. Hepatic Impairment with Model for End-Stage Liver Disease (MELD) score ≥ 30 or listed for liver transplant.
  8. 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
Layout table for location contacts
Contact: Heidi Moran 800-791-1021 hmoran@directbiologics.com

Sponsors and Collaborators
Direct Biologics, LLC
Publications:
Layout table for additonal information
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: July 12, 2021
Last Verified: July 2021
Keywords provided by Direct Biologics, LLC:
COVID-19
ARDS
SARS-CoV-2
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Hypoxia
Cytokine Release Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock