Status:
UNKNOWN
Extracellular Vesicles From Mesenchymal Cells in the Treatment of Acute Respiratory Failure
Lead Sponsor:
D'Or Institute for Research and Education
Collaborating Sponsors:
Hospital Sao Rafael
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conditions:
Severe Acute Respiratory Syndrome (SARS)
Acute Respiratory Distress Syndrome (ARDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 mesenc...
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...
Eligibility Criteria
Inclusion
- Age \>= 18 years old;
- Chest CT radiological image with ground-glass opacities or chest X-ray with - bilateral infiltrates characteristic of pulmonary edema;
- In invasive mechanical ventilation with PEEP 5 cm H2O and PaO2/FiO2\<250mmHg;
- Respiratory failure not explained by cardiac causes or fluid overload.
Exclusion
- Unable to provide informed consent;
- Pregnancy or breastfeeding;
- Patients with active malignancy who have received chemotherapy in the last 2 years;
- Life expectancy of less than 6 months or in exclusive palliative care;
- Severe liver failure, with a Child-Pugh score \> 12;
- Previous renal failure: patients already undergoing dialysis or patients with GFR \< 30ml/min/1.73 m2
- Clinical or radiological suspicion of tuberculosis;
- Chronic respiratory failure;
- Use of ECMO;
- Moribund (high probability of death within the next 48 hours).
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06002841
Start Date
February 1 2024
End Date
June 1 2025
Last Update
August 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital São Rafael
Salvador, Estado de Bahia, Brazil, 41253-190