A Comparison Study of Repeated Intravenous Infusion of Allogeneic Mesenchymal Stem Cell from Different Sources in ARDS Patients
Phase 1
Recruiting
- Conditions
- Acute respiratory distress syndrome (ARDS).Acute respiratory distress syndrome
- Registration Number
- IRCT20080901001165N44
- Lead Sponsor
- Bagheiat-allah University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Signed informed consent voluntarily
Confirmed ARDS
SOFA score between 2-3 point
PaO2/FIO2 = 300 mmHg
Mild to Moderate pneumonia/ stay in the ICU <48 hours
Pulmonary imaging shows that the focus progress > 50% in 24-48 hours
Exclusion Criteria
Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus
Liver or kidney SOFA score of more than 3 points; combined with other organ failure
Patients with malignant tumor
Pregnant or lactating women
Uncontrolled underling diseases
Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia
In vitro life support (ECMO, ECCO2R, RRT)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths). Timepoint: Before Intervention, Day 0 (First Intervention) till Day 7, Day 14, Day 28, 3 Moths, 6 Months and 12 months after intervention. Method of measurement: Fill Common Terminology Criteria for Adverse Events (CTCAE) Form.
- Secondary Outcome Measures
Name Time Method PaO2/FiO2 assessment. Timepoint: Before Intervention, Day 0 (First Intervention) till Day 7, Day 14, Day 28, 3 Moths, 6 Months and 12 months after intervention. Method of measurement: Ventilator.