Using exosomes to prevent worsening in patients with mild to moderate ARDS
A Phase IIb, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Mild-Moderate ARDS
PHASE2 · Nano24med · NCT05947747
This study is testing if a new treatment using exosomes can help people with mild to moderate Acute Respiratory Distress Syndrome (ARDS) avoid getting worse.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nano24med (other) |
| Locations | 1 site (Tel-Aviv) |
| Trial ID | NCT05947747 on ClinicalTrials.gov |
What this trial studies
This phase IIb clinical trial evaluates the safety and efficacy of EXO-CD24, a treatment involving exosomes overexpressing CD24, in preventing clinical deterioration in patients diagnosed with mild to moderate Acute Respiratory Distress Syndrome (ARDS). The study will enroll 90 patients who will be randomized in a 2:1 ratio to receive either the treatment or a placebo, with the treatment administered via a nebulizer twice daily for five days. Patients will be monitored for an additional 23 days post-treatment to assess outcomes and safety. The study aims to provide insights into the potential of exosome therapy in managing ARDS.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with mild to moderate ARDS and specific laboratory markers indicating a risk for cytokine storm.
Not a fit: Patients with severe ARDS requiring mechanical ventilation or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with mild to moderate ARDS by preventing clinical deterioration.
How similar studies have performed: While the use of exosomes in clinical settings is emerging, this specific approach has not been widely tested, making it a novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Direct and indirect lung injury etiology 2. Age ≥18 years 3. Patients with Early Acute Lung Injury (EALI) \> 2 ,or patient on HFNC/NIPPV \[(1 point for an oxygen requirement \> 2 to 6 liters/min or 2 points for \> 6 liters/min; 1 point each for a respiratory rate ≥ 30 breaths/min and baseline immune suppression) (immune system compromised by exogenous drug etc.)\] (For saturation goal \>90%) \[1\], or ARDS diagnosis (mild/moderate) 4. Willing and able to sign an informed consent, or has a legal guardian who is able to sign Exclusion Criteria: 1. Any concomitant illness that, based on the judgment of the investigator might affect the interpretation or the results of the study (immunodeficiency, primary immune deficiency due to virus, hematological malignancy etc.) 2. Patients with SaO2/FiO2\<150 3. Patients with mechanical ventilation (ECMO). 4. Pregnancy \[positive urine pregnancy test (women of childbearing potential only)\] or breastfeeding 5. Participation in any other interventional study in the last 30 days or within 5 half-lives of receiving an investigational agent.
Where this trial is running
Tel-Aviv
- Tel-Aviv Sourasky Medical Center — Tel-Aviv, Israel (RECRUITING)
Study contacts
- Study coordinator: Nimrod Adi, MD
- Email: nimroda@tlvmc.gov.il
- Phone: +972-524266719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ARDS