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Recruiting NCT05354141

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

Phase III Interventional Acute Respiratory Distress Syndrome ARDS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ExoFlo, Intravenous normal saline.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome, ARDS. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Biological ExoFlo
    Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
  • Other Intravenous normal saline
    Placebo

Primary outcome measures

  • Evaluation of 60-day All-cause Mortality [Time frame: 60 days]
Secondary outcome measures (5)
  • Time to death [Time frame: 60 days]
  • Ventilator-free days (VFDs) [Time frame: Day 29]
  • Oxygen free days [Time frame: Day 29]
  • ICU free days [Time frame: Day 29]
  • Incidence of Treatment Emergent Serious Adverse Events (TESAEs) [Time frame: 61 days]

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.
  • Severe metabolic disturbances at randomization (e.g., ketoacidosis, pH < 7.2)
  • Patient currently connected to Extracorporeal Membrane Oxygenation at initiation of screening.
  • If the candidate, either a male or female of reproductive potential, is unwilling to two methods of highly effective birth control contraception such as condoms with oral contraceptive pill or choose to remain abstinent if already practicing abstinence during the screening period. The required duration of usage of double method OR maintenance of abstinence must include the time from the beginning of the screening period until Day 61, day of withdrawal or early termination
  • Use of investigational COVID-19 agents or any other investigational agents within 30 days prior to the first dose.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 32 centers
  • Direct Biologics Investigational Site — Phoenix
  • Direct Biologics Investigational Site — Little Rock
  • Direct Biologics Investigational Site — Davis
  • Direct Biologics Investigational Site — Irvine
  • Direct Biologics Investigational Site — Sacramento
  • Direct Biologics Investigational Site — Washington D.C.
  • Direct Biologics Investigational Site — Jacksonville
  • Direct Biologics Investigational Site — Boise
  • … and 24 more centers

Identifiers

NCT: NCT05354141 · DB-EF-PHASEIII-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗