NCT06002841

Extracellular Vesicles From Mesenchymal Cells in the Treatment of Acute Respiratory Failure

Extracellular Vesicles From Mesenchymal Cells in the Treatment of Acute Respiratory Failure Associated With SARS-CoV-2 and Other Etiologies: a Clinical Trial, Randomized, Double-blind.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: D'Or Institute for Research and Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II, randomized, double-blind, placebo-controlled clinical trial that will evaluate the safety and potential efficacy of therapy with extracellular vesicles (EVs) obtained from mesenchymal stromal cells (MSCs), patients with moderate to severe acute respiratory distress syndrome due to COVID-19 or other etiology. Participants will be allocated to receive EVs obtained from MSCs or placebo (equal volume of Plasma-Lyte A). Blinding will cover the participants, the multidisciplinary intensive care team and the investigators.

Detailed description

The studied population will consist of 15 patients diagnosed with acute respiratory failure syndrome admitted to the intensive care unit of Hospital São Rafael. This research aims to assess the safety and potential effectiveness of intravenous therapy using extracellular vesicles derived from mesenchymal cells in patients with moderate to severe acute respiratory distress syndrome. The treatment group will receive intravenous administration of extracellular vesicles obtained from mesenchymal cells, while the control group will receive a placebo. EV group: will consist of 10 participants who will receive two infusions of 25 mL of the investigational product (Plasma-Lyte A solution containing EVs obtained from MSCs), intravenously, at intervals of 48 h. Placebo group: will consist of 5 participants who will receive an equal volume of Plasma-Lyte A, intravenously, following the same schedule as the IV group: two infusions with an interval of 48 hours.

Conditions

• Severe Acute Respiratory Syndrome (SARS)
• Acute Respiratory Distress Syndrome (ARDS)
• Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	intravenous treatment with EVs	intravenous treatment with extracellular vesicles
BIOLOGICAL	intravenous treatment with placebo solution	intravenous treatment with placebo solution (without extracellular vesicles)

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2023-08-21
• Last updated: 2023-08-21

Locations

1 site across 1 country: Brazil