Treatment for Acute Respiratory Distress Syndrome using Extracellular Vesicles

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III clinical trial evaluates the safety and efficacy of ExoFlo, an intravenous treatment derived from bone marrow mesenchymal stem cell extracellular vesicles, in hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). The study is multicenter, randomized, and double-blinded, comparing ExoFlo to a placebo. Participants will be monitored for improvements in respiratory function and overall health outcomes. The trial aims to provide a new therapeutic option for patients suffering from this severe condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Where it's running

• Direct Biologics Investigational Site
  Phoenix, Arizona, United States Recruiting
• Direct Biologics Investigational Site
  Little Rock, Arkansas, United States Recruiting
• Direct Biologics Investigational Site
  Davis, California, United States Recruiting
• Direct Biologics Investigational Site
  Irvine, California, United States Recruiting
• Direct Biologics Investigational Site
  Sacramento, California, United States Recruiting
• Direct Biologics Investigational Site
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Bill Arana
• Email: clinicalaffairs@directbiologics.com
• Phone: 1-800-791-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Innovative therapies for Acute Respiratory Distress Syndrome

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• Evaluating vilobelimab for treating Acute Respiratory Distress Syndrome

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• Evaluating a new treatment for Acute Respiratory Distress Syndrome

  This study is testing a new treatment called paridiprubart to see if it can help hospitalized adults with Acute Respiratory Distress Syndrome breathe better and improve their chances of recovery.

  Recruiting at 28 sites Phase 2 PPD Development, LP · Birmingham, Alabama and 40 other locations · NCT06701669

• Evaluating Bevacizumab for Acute Respiratory Distress Syndrome

  This study is testing whether a medication called bevacizumab can help hospitalized adults with Acute Respiratory Distress Syndrome breathe better and improve their chances of recovery.

  Recruiting at 28 sites Phase 2 PPD Development, LP · Birmingham, Alabama and 40 other locations · NCT06701656

• Multicenter group study of sepsis and ARDS in China

  This study tests how sepsis and ARDS differ among adults across several Chinese hospitals and builds a biobank to understand why some patients do better or worse.

  Recruiting at 24 sites Shanghai Zhongshan Hospital · Xiamen, Fujian and 23 other locations · NCT07863908

• Blood viscosity in ARDS: a look at how thick the blood is

  This study tests whether blood viscosity is higher in adults with ARDS and whether viscosity relates to their breathing and blood flow issues.

  Recruiting Hospices Civils de Lyon · Lyon · NCT07823296

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.