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

NCT06002841 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-08-21

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

intravenous treatment with EVs

intravenous treatment with extracellular vesicles

BIOLOGICAL

intravenous treatment with placebo solution

intravenous treatment with placebo solution (without extracellular vesicles)

Sponsors & Collaborators

  • Hospital Sao Rafael

    collaborator OTHER

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

    collaborator OTHER_GOV

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • D'Or Institute for Research and Education

    lead OTHER

Principal Investigators

  • Bruno Souza, M.D · Instituto D'Or de Pesquisa e Ensino (IDOR), Salvador, Brazil

  • Patrícia Rocco, M.D · Universidade Federal do Rio de Janeiro (UFRJ)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06002841 on ClinicalTrials.gov