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

Sponsor

Direct Biologics, LLC (Industry)

Overall Status

Available

CT.gov ID

NCT04657458

Collaborator

(none)

Study Details

Study Description

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	Phase
Covid19 ARDS Hypoxia Cytokine Storm	Biological: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment

Study Design

Study Type:

Expanded Access

Official Title:

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment: A Global Expanded Access Protocol for Patients With COVID-19 Associated ARDS Who Do Not Qualify for Phase II Randomized Control Trial

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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 pregnantunless the patient has one or more conditions listed under Exclusion Criteria #4.
PositiveReverse 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.
Acute presentation of hypoxic respiratory failurerequiring noninvasive oxygen support OR mechanical ventilation (MV).
Agreementto use highly effective birth control contraceptionif 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 <15mL/min/1.73m2)or listed forkidneytransplant.
Hepatic Impairment with Model for End-Stage Liver Disease (MELD) score ≥ 30or listed for liver transplant.
Use of extracorporeal membrane oxygenation (ECMO) during the current hospitalization.