Actively Recruiting
Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
Led by Direct Biologics, LLC · Updated on 2026-02-23
970
Participants Needed
32
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 75 years
- Diagnosis of moderate to severe ARDS within 24 hours before the first infusion, defined by Berlin Criteria
- Onset of ARDS within 7 days of a known clinical insult or increased breathing effort
- Bilateral lung opacities not explained by other causes such as pleural effusion or nodules
- PaO2/FiO2 (P/F ratio) less than or equal to 200 mm Hg
- Receiving invasive or noninvasive ventilation with minimum PEEP of 5 cm H2O, or CPAP of 5 cm H2O, or High Flow Nasal Oxygen at 30 L/min or more
- Respiratory failure not caused by heart failure or fluid overload
You will not qualify if you...
- Lack of signed informed consent
- Unwillingness to comply with study procedures or availability for study duration
- Pregnant patients, children, or individuals unable to provide meaningful consent
- Active cancer requiring treatment in the last 2 years, except non-melanoma skin cancers
- Major physical trauma in the last 2 days that may cause undiagnosed injuries
- Mechanical ventilation for more than 3 days or 72 hours from ARDS diagnosis
- Liver enzyme levels (ALT or AST) greater than 8 times the upper limit of normal
- History of cirrhosis
- Do Not Resuscitate (DNR) order
- Expected survival less than 24 hours
- Severe metabolic disturbances at screening (e.g., ketoacidosis, pH less than 7.2)
- Connected to Extracorporeal Membrane Oxygenation at screening
- Unwillingness to use two highly effective birth control methods or maintain abstinence from screening until day 61
- Use of investigational COVID-19 or other agents within 30 days before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Direct Biologics Investigational Site
Phoenix, Arizona, United States, 85012
Actively Recruiting
2
Direct Biologics Investigational Site
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Direct Biologics Investigational Site
Davis, California, United States, 95817
Actively Recruiting
4
Direct Biologics Investigational Site
Irvine, California, United States, 92627
Actively Recruiting
5
Direct Biologics Investigational Site
Sacramento, California, United States, 95817
Actively Recruiting
6
Direct Biologics Investigational Site
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
7
Direct Biologics Investigational Site
Jacksonville, Florida, United States, 32224
Actively Recruiting
8
Direct Biologics Investigational Site
Boise, Idaho, United States, 83712
Actively Recruiting
9
Direct Biologics Investigational Site
Iowa City, Iowa, United States, 52242
Actively Recruiting
10
Direct Biologics Investigational Site
Silver Spring, Maryland, United States, 20910
Actively Recruiting
11
Direct Biologics Investigational Site
Boston, Massachusetts, United States, 02115
Actively Recruiting
12
Direct Biologics Investigational Site
Burlington, Massachusetts, United States, 01805
Actively Recruiting
13
Direct Biologics Investigational Site
Springfield, Massachusetts, United States, 01199
Actively Recruiting
14
Direct Biologics Investigational Site
Detroit, Michigan, United States, 48202
Actively Recruiting
15
Direct Biologics Investigational Site
Rochester, Minnesota, United States, 55905
Actively Recruiting
16
Direct Biologics Investigational Site
Jackson, Mississippi, United States, 39202
Actively Recruiting
17
Direct Biologics Investigational Site
Flushing, New York, United States, 11368
Actively Recruiting
18
Direct Biologics Investigational Site
Queens, New York, United States, 11040
Actively Recruiting
19
Direct Biologics Investigational Site
The Bronx, New York, United States, 10467
Actively Recruiting
20
Direct Biologics Investigational Site
Durham, North Carolina, United States, 27710
Actively Recruiting
21
Direct Biologics Investigational Site
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
22
Direct Biologics Investigational Site
Cincinnati, Ohio, United States, 45219
Actively Recruiting
23
Direct Biologics Investigational Site
Cleveland, Ohio, United States, 44106
Actively Recruiting
24
Direct Biologics Investigational Site
Portland, Oregon, United States, 97239
Actively Recruiting
25
Direct Biologics Investigational Site
Charleston, South Carolina, United States, 29425
Actively Recruiting
26
Direct Biologics Investigational Site
Knoxville, Tennessee, United States, 37996
Actively Recruiting
27
Direct Biologics Investigational Site
Nashville, Tennessee, United States, 37235
Actively Recruiting
28
Direct Biologics Investigational Site
Dallas, Texas, United States, 75246
Actively Recruiting
29
Direct Biologics Investigational Site
Fort Worth, Texas, United States, 76104
Actively Recruiting
30
Direct Biologics Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
31
Direct Biologics Investigational Site
Murray, Utah, United States, 84107
Not Yet Recruiting
32
Direct Biologics Investigational Site
Salt Lake City, Utah, United States, 84101
Actively Recruiting
Research Team
B
Bill Arana
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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