Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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).

Official Title

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

Details

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

Keywords

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

Eligibility

You can join if…

Open to people ages 18-75

  1. Men and women aged 18-75 years of age
  2. Presence of the following criteria for moderate to severe ARDS as defined by the

    Berlin Criteria within 24 hours of the first infustion:

    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, or High Flow Nasal Oxygen at ≥ 30 L/min, 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 > 8 x Upper Limit of Normal (ULN).
  8. Documented history of cirrhosis.
  9. DNR order, as in electing not to receive chest compressions, cardiac defibrillation, cardiac drugs, or intubation.

    10. Moribund-expected survival < 24 hours. 11. Severe metabolic disturbances at randomization (e.g., ketoacidosis, pH < 7.2) 12. Patient currently connected to Extracorporeal Membrane Oxygenation at initiation of

    screening.

    13. 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

    14. Use of investigational COVID-19 agents or any other investigational agents within 30

    days prior to the first dose.

Locations

  • Direct Biologics Investigational Site accepting new patients
    San Francisco California 94143 United States
  • Direct Biologics Investigational Site accepting new patients
    Orange California 92868 United States
  • Direct Biologics Investigational Site accepting new patients
    Sacramento California 95817 United States
  • Direct Biologics Investigational Site accepting new patients
    Fullerton California 92835 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Direct Biologics, LLC
Links
Direct Biologics, LLC
ID
NCT05354141
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 970 study participants
Last Updated