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

NCT04657458 | Unknown

• 1 other identifier: DB-EF-EXPANDEDACCESS-001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

COVID-19; ARDS; SARS-CoV-2

Interventions

ExoFlo BIOLOGICAL

Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) SARS-CoV-2.
• Moderate to severe ARDS as defined by timing within ten days 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, minimum 5 cm H2O PEEP on mechanical ventilation, and PaO2/FiO2 ≤ 200 mmHg (if using an estimated P/F ratio, a S/F ≤ 235 is accepted).
• Acute presentation of hypoxic respiratory failure requiring noninvasive oxygen support OR mechanical ventilation (MV).
• Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers.
• Patients who are not full code.
• Pregnant patients with current or past history of eclampsia, preeclampsia, hemolysis, elevated liver enzymes, or 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.

Sponsors & Collaborators

• Direct Biologics, LLC: lead

Related Links

• Direct Biologics, LLC

MeSH Terms

Conditions

COVID-19; Hypoxia; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Shock

Study Officials

• Bill Arana

  Direct Biologics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 8, 2020
• Last Updated: November 22, 2024

Record last verified: 2024-11