Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDirect Biologics, LLC
About this trial
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).
Eligibility criteria
Qualifiers
Men and women aged 18-75 years of age
Onset within 7 days of known clinical insult or requiring increasing respiratory rate, increasing oxygen flows, or increased work of breathing, and
Bilateral lung opacities not fully explained by pleural effusions, atelectasis, or nodules, and
PaO2/FiO2 (P/F ratio) ≤ 200 mm Hg, and
Disqualifiers
Lack of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).
Stated unwillingness to comply with all study procedures and availability for the duration of the study
Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent.
Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers.
Trial design
Treatments tested in this trial
- ExoFlo
- Intravenous normal saline
Treatment groups
970 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov