for people ages 18-65 (full criteria)
at Orange, California and other locations
study started
estimated completion



To evaluate the safety and efficacy of intravenous administration of bone marrow derived extracellular vesicles, ExoFlo, versus placebo as treatment for hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).

Official Title

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


This is a Phase III, multicenter, randomized, double-blinded, placebo-controlled trial for the treatment of moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).


Acute Respiratory Distress Syndrome, ARDS, ExoFlo, Extracellular Vesicles, Exosome, Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Acute Lung Injury, Syndrome, Intravenous normal saline


You can join if…

Open to people ages 18-65

  1. Men and women aged 18-65 years of age
  2. Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria
    1. Onset within 7 days of known clinical insult or requiring increasing respiratory rate, increasing oxygen flows, or increased work of breathing, and
    2. Bilateral lung opacities not fully explained by pleural effusions, atelectasis, or nodules, and
    3. PaO2/FiO2 (P/F ratio) ≤ 200 mm Hg, and
    4. Invasive or noninvasive ventilation with a minimum PEEP 5 cm H2O or minimum of continuous positive airway pressure (CPAP) 5 cm H2O, and
    5. Respiratory failure not fully explained by cardiac failure or fluid overload.

You CAN'T join if...

  1. Lack of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).
  2. Stated unwillingness to comply with all study procedures and availability for the duration of the study
  3. Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent.
  4. Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers.
  5. 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.
  6. Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis of ARDS.
  7. ALT or AST > 5 x Upper Limit of Normal (ULN).
  8. Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min unless receiving RRT.
  9. Overt Disseminated Intravascular Coagulopathy (DIC) as evidenced by a total score of ≥ 5 on the following DIC score from International Society of Thrombosis & Hemostasis:
    • INR ≤ 1.3 (0 Points); 1.3- 1.7 (1 Point); > 1.7 (2 Points)
    • Fibrinogen > 100 mg/dL (0 Points); < 100 mg/dL (1 Point)
    • D-dimer < 400 ng/dL (0 Points); 400-4000 ng/mL (2 Points); >4,000 ng/ml (3 Points)
    • Platelets > 100,000/uL (0 Points); 50,000-100,000/uL (1 Point); < 50,000/uL (2 Points)
      1. DNR order, as in electing not to receive chest compressions, cardiac defibrillation, cardiac drugs, or intubation.
        1. Moribund-expected survival < 24 hours.
        2. Severe metabolic disturbances at randomization (e.g., ketoacidosis, pH < 7.2)
        3. Patient currently connected to Extracorporeal Membrane Oxygenation at initiation of screening.
        4. If the candidate, either a male or female of reproductive potential, is unwilling to use of double barrier method 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 barrier 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


  • UC Irvine accepting new patients
    Orange California 92868 United States
  • Providence St. Jude Medical Center accepting new patients
    Fullerton California 92835 United States


accepting new patients
Start Date
Completion Date
Direct Biologics, LLC
Direct Biologics, LLC
Phase 3 research study
Study Type
Expecting 320 study participants
Last Updated