The effects of mesenchymal stem cells in COVID-19

Phase 1

Recruiting

Conditions: Acute Respiratory Distress Syndrome.
Acute respiratory distress syndrome

Registration Number: IRCT20200621047859N4

Lead Sponsor: Modiriat Atiye Bahman Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

COVID-19 infection confirmed with positive PCR test results with clinical signs including respiratory distress, cough, fever, decreased blood oxygen saturation, and imaging results in favor of ARDS
Over 18 years of age
Bilateral opacity of lungs on CT scan
PaO2/FiO2 ratio < 200
Requires mechanical ventilation to increase oxygen saturation
Written informed consent (according to the patient's condition, in case of unconscious consent, the consent will be obtained from the patient's guardian).

Exclusion Criteria

Less than 18 years of age
More than 96 hours passed from the diagnosis of ARDS (Based on the Berlin definition of ARDS)
Pregnancy or breastfeeding
Presence of active malignancy which has been treated in the past two years
Presence of severe and irreversible disease with a life expectancy of less than 6 months
Moderate to severe liver failure (Childs-Pugh Score> 12)
History of chronic lung disease with PaCO2>50 mm Hg or history of oxygen consumption at home
Extensive trauma in the past 5 days
History of lung transplantation
Inability to provide informed consent or meet test conditions
Class 3 or 4 pulmonary hypertension (WHO classification)
History of pulmonary embolism or deep vein thrombosis (DVT) in the past three months

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of PLMSCs intravenous injection. Timepoint: During hospitalization up to 28 days after treatment. Method of measurement: Physical examinations and blood tests.;Change the amount of oxygen supply. Timepoint: Up to 28 days after treatment. Method of measurement: Measurement of PaO2 / FiO2.;Mortality. Timepoint: Up to 28 days after intervention. Method of measurement: The patients follow up.;Change in the severity of pneumonia. Timepoint: During hospitalization up to 28 days after treatment. Method of measurement: Physical examination - percentage of oxygen in the ventilator.

Secondary Outcome Measures

Name	Time	Method
Investigation of visceral insufficiency. Timepoint: Up to 28 days after transplantation. Method of measurement: Perform liver and kidney function tests on days 0, 7, 14 and 28.;C-reactive protein changes. Timepoint: Daily to +28. Method of measurement: Measurement of blood C-reactive protein.;Change in the number of lymphocytes. Timepoint: Day zero to week 12. Method of measurement: blood test.;Lung CT scan changes. Timepoint: Within 28 days after treatment. Method of measurement: Perform a CT scan of the lungs.;Duration of ICU admission. Timepoint: at the time of ICU discharge. Method of measurement: Number of admission days.