Acute Respiratory Distress Syndrome of COVID-19. COVID-19
Conditions
Interventions
Intervention group: (n=6). Patients will receive three doses of MSCs. Three doses of 200×10e6 (±10%) cells will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusio
Sponsors
Iranian academic center for education culture and research
National Institute for Medical Research Development
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMorteza Zarrabi
Royan Institute
Outcome results
None listed