Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles for Hospitalized Patients With Moderate-to-Severe ARDS: A Phase III Clinical Trial

Direct Biologics, LLC32 sites in 1 country970 target enrollmentJuly 1, 2022

ConditionsAcute Respiratory Distress Syndrome ARDS

InterventionsIntravenous normal saline ExoFlo

DrugsExoFlo

Overview

Phase: Phase 3
Intervention: Intravenous normal saline
Conditions: Acute Respiratory Distress Syndrome
Sponsor: Direct Biologics, LLC
Enrollment: 970
Locations: 32
Primary Endpoint: Evaluation of 60-day All-cause Mortality
Status: Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

July 1, 2022

End Date

December 31, 2027

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Direct Biologics, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and women aged 18-75 years of age
•Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infustion:
•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
•Invasive or noninvasive ventilation with a minimum PEEP 5 cm H2O or minimum of continuous positive airway pressure (CPAP) 5 cm H2O, or High Flow Nasal Oxygen at ≥ 30 L/min, and
•Respiratory failure not fully explained by cardiac failure or fluid overload.

Exclusion Criteria

•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.
•Major physical trauma in the last 2 days, including motor vehicle accidents, assaults, mechanical falls with sequelae of significant bleeding or craniofacial bruising, and surgeries, such that not one or more injury may be undiagnosed at time of screening.
•Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis of ARDS.
•ALT or AST \> 8 x Upper Limit of Normal (ULN).
•Documented history of cirrhosis.
•DNR order, as in electing not to receive chest compressions, cardiac defibrillation, cardiac drugs, or intubation.
•Moribund-expected survival \< 24 hours.

Arms & Interventions

Placebo

Normal saline 100 mL

Intervention: Intravenous normal saline

Experimental Dose

Normal saline 85 mL and ExoFlo 15 mL

Intervention: ExoFlo

Outcomes

Primary Outcomes

Evaluation of 60-day All-cause Mortality

Time Frame: 60 days

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.