MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome
Phase 1
- Conditions
- Covid19ARDS, Human
- Interventions
- Other: Mesenchymal stromal cell-based therapy
- Registration Number
- NCT04525378
- Lead Sponsor
- D'Or Institute for Research and Education
- Brief Summary
Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Clinical diagnosis of COVID-19 confirmed by RT-PCR;
- Thorax CT image suggestive of viral pneumonia;
- Respiratory failure (SaO2 <93% with O2 at 5L / min)
- Tracheal intubation (first 48 h);
Exclusion Criteria
- Pregnancy or breastfeeding;
- Patients with a history of cancer, chemotherapy in the past 2 years;
- Life expectancy less than 6 months or in exclusive palliative care;
- Severe liver failure, with Child-Pugh score> 12;
- High probability of death in the following 48 h;
- Previous renal failure: patients who were already on dialysis or patients with RFG <30ml / min / 1.73 m2;
- Clinical or radiological suspicion of tuberculosis and bacterial pneumonia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MSC - high dose (10x10ˆ7) Mesenchymal stromal cell-based therapy Patients will receive standard care plus cell therapy. MSC - low dose (2.5x10ˆ7) Mesenchymal stromal cell-based therapy Patients will receive standard care plus cell therapy. MSC - intermediate dose (5x10ˆ7) Mesenchymal stromal cell-based therapy Patients will receive standard care plus cell therapy.
- Primary Outcome Measures
Name Time Method Intrahospital mortality 28 days
- Secondary Outcome Measures
Name Time Method PaO2 / FiO2 ratio Day 1, Day 2 and Day 7 after cell infusion Incidence of adverse events 28 days Quantification of inflammatory response markers Day 1, Day 3 and Day 7 after cell infusion Exploratory evaluation of changes from baseline (percentage) in serum levels of CRP, LDH, Ferritin levels, a panel of cytokines, chemokines immune cell populations by flow cytometry
Days without mechanical ventilation in 28 days 28 days Incidence of secondary infections 28 days Length of stay in the ICU and Hospital 28 days
Trial Locations
- Locations (1)
Hospital São Rafael
🇧🇷Salvador, Bahia, Brazil