Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infectio
Phase 1
- Conditions
- Acute Respiratory Distress Syndrome of COVID-19.COVID-19U07.1
- Registration Number
- IRCT20200217046526N1
- Lead Sponsor
- Iranian academic center for education culture and research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
Informed consent
Male or female
18-70 years old
ARDS diagnosed
SOFA score between 2-13 point
Requiring mechanical ventilation and/or supplemental oxygen
Pneumonia that is judged by chest radiograph or CT scan or confirmation of SARS-CoV-2 infection by qRT-PCR
PaO2/oxygen absorption concentration (FiO2) = 300 mmHG
Exclusion Criteria
Presenting severe allergies after 1st injection of stem cell
Patients with a malignant tumor and psychosis
Co-Infection of HIV, tuberculosis, adenovirus and another respiratory infection virus
Patients with previous history of pulmonary embolism
Moribund patient expecting death within 48 hours
Continuous use of immunosuppressive agents or organ transplants in the past 6 months
Pregnancy or breastfeeding
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events assesment. Timepoint: At the same time of each intervention, 24 hours after each intervention, on days 6, 7, 14 and 28 after the first intervention. Method of measurement: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
- Secondary Outcome Measures
Name Time Method Blood oxygen saturation. Timepoint: At Baseline, simultaneously with each intervention and on days 5, 6, 7, 14 after the first intervention. Method of measurement: Evaluation of Pneumonia Improvement.