Health TrialsbyHealthPanel

Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)

ConditionsAcute Respiratory Distress SyndromeARDS
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ExoFlo

    Biological/Vaccine

    Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles

  • Intravenous normal saline

    Other intervention

    Placebo

Treatment groups

970 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Experimental DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of 60-day All-cause Mortality

To evaluate the 60-day mortality rate for IMP 15mL as a treatment for moderate-to-severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with moderate-to-severe ARDS is a measure of the treatment effect.

Time frame
60 days

Secondary outcomes

1

Time to death

Reducing the mortality rate for hospitalized patients moderate-to-severe ARDS is a measure of the treatment effect.

Time frame
60 days
2

Ventilator-free days (VFDs)

Number of days for which patients are not on mechanical ventilation.

Time frame
Day 29
3

Oxygen free days

Number of days for which patients are not on oxygen support.

Time frame
Day 29
4

ICU free days

Number of days for which patients are not in the ICU.

Time frame
Day 29

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Direct Biologics, LLC

Lead sponsor

Source ClinicalTrials.gov
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