Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
Start Date
7/1/2022
Completion Date
12/31/2027
Summary
To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).
Detailed Description
This is a Phase III, multicenter, randomized, double-blinded, placebo-controlled trial for the treatment of moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
ExoFlo
Intravenous normal saline
Conditions
Locations
Direct Biologics Investigational Site
Phoenix, Arizona 85012
United States
Direct Biologics Investigational Site
Little Rock, Arkansas 72205
United States
Direct Biologics Investigational Site
Davis, California 95817
United States
Direct Biologics Investigational Site
Irvine, California 92627
United States
Direct Biologics Investigational Site
Sacramento, California 95817
United States
Direct Biologics Investigational Site
Washington D.C., District of Columbia 20010
United States
Direct Biologics Investigational Site
Jacksonville, Florida 32224
United States
Direct Biologics Investigational Site
Boise, Idaho 83712
United States
Direct Biologics Investigational Site
Iowa City, Iowa 52242
United States
Direct Biologics Investigational Site
Silver Spring, Maryland 20910
United States
Direct Biologics Investigational Site
Boston, Massachusetts 02115
United States
Direct Biologics Investigational Site
Burlington, Massachusetts 01805
United States
Direct Biologics Investigational Site
Springfield, Massachusetts 01199
United States
Direct Biologics Investigational Site
Detroit, Michigan 48202
United States
Direct Biologics Investigational Site
Rochester, Minnesota 55905
United States
Direct Biologics Investigational Site
Jackson, Mississippi 39202
United States
Direct Biologics Investigational Site
Flushing, New York 11368
United States
Direct Biologics Investigational Site
Queens, New York 11040
United States
Direct Biologics Investigational Site
The Bronx, New York 10467
United States
Direct Biologics Investigational Site
Durham, North Carolina 27710
United States
Direct Biologics Investigational Site
Winston-Salem, North Carolina 27157
United States
Direct Biologics Investigational Site
Cincinnati, Ohio 45219
United States
Direct Biologics Investigational Site
Cleveland, Ohio 44106
United States
Direct Biologics Investigational Site
Portland, Oregon 97239
United States
Direct Biologics Investigational Site
Charleston, South Carolina 29425
United States
Direct Biologics Investigational Site
Knoxville, Tennessee 37996
United States
Direct Biologics Investigational Site
Nashville, Tennessee 37235
United States
Direct Biologics Investigational Site
Dallas, Texas 75246
United States
Direct Biologics Investigational Site
Fort Worth, Texas 76104
United States
Direct Biologics Investigational Site
Houston, Texas 77030
United States
Direct Biologics Investigational Site
Murray, Utah 84107
United States
Direct Biologics Investigational Site
Salt Lake City, Utah 84101
United States