Exosomes Derived from placental Mesenchymal Stem Cells as Treatment for Severe COVID-19: Phase 1 & 2 Clinical Trials
- Conditions
- Acute Respiratory Distress Syndrome of COVID-19.COVID-19U07.1
- Registration Number
- IRCT20200413047063N2
- Lead Sponsor
- Omid Cell and Tissue center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Confirmation of 2019-nCoV infection by RT-PCR Diagnosis of ARDS according to the Berlin definition of ARDS Requiring supplemental oxygen, PaO2/oxygen absorption concentration (FiO2) = 300MMHG Pulmonary imaging shows that the focused progress > 50% in 24-48 hours Mild to Moderate 2019-nCoV pneumonia/ stay in the ICU <48 hours SOFA score between 2-3 point Pneumonia that is judged by chest radiograph or CT
Severe allergies or allergies after 1st injection to stem cell preparations and their components Patients with a malignant tumor, other serious systemic diseases, and psychosis Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus Patients with previous history of pulmonary embolism Liver or kidney SOFA score of more than 3 points; combined with other organ failure (need organ support), Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30) Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia Continuous use of immunosuppressive agents or organ transplants in the past 6 months In vitro life support (ECMO, ECCO2R, RRT) Pregnant or lactating women Uncontrolled underlying disease Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections)
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, 12 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 Biomarkers concentrations in plasma. Timepoint: At baseline, 7, 14, 28 days after the first intervention. Method of measurement: Biochemical examination.;Respiratory efficacy. Timepoint: From baseline to day 7. Method of measurement: Evaluated by the increase in PaO2/FiO2 ratio.;Intensive care unit-free days. Timepoint: Up to day 8. Method of measurement: Number of day.;Change in clinical symptoms. 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.