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IRCT20200621047859N4 IRCT 2021-01-03 Modiriat Atiye Bahman Company The effects of mesenchymal stem cells in COVID-19 Human Placenta-Derived Mesenchymal Stem Cell Transplantation in Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19: Phase I Clinical Trial) 2020-10-28 anticipated 20 Complete https://irct.ir/trial/52947 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Acute Respiratory Distress Syndrome. Intervention group: Patients with resistant pneumonia caused by COVID-19 infection with acute symptoms of ARDS who have not responded to routine treatments. This group will receive about 10^6 cells/Kg Good manufacturing practices (GMP)-grade mesenchymal stem cells infusion over 10 minutes. The common treatments of patients will not be stopped.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Decision will be made after sampling
public Dr Ramin Sarrami Forooshani
No.146, Vanaq Square, South Ghandi, Tehran, Iran
Tehran Iran (Islamic Republic of) 1517964311 +98 21 8879 6003 rsf1351@gmail.com Iranian academic center for education culture and research scientific Dr Ramin Sarrami Forooshani
No.146, Vanaq Aquare, South Ghandi, Tehran, Iran
Tehran Iran (Islamic Republic of) 1517964311 +98 21 8879 6003 rsf1351@gmail.com Iranian academic center for education culture and research Iran (Islamic Republic of) 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). 18 years no limit Both 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 J80 Acute respiratory distress syndrome Treatment - Other Intervention group: Patients with resistant pneumonia caused by COVID-19 infection with acute symptoms of ARDS who have not responded to routine treatments. This group will receive about 10^6 cells/Kg Good manufacturing practices (GMP)-grade mesenchymal stem cells infusion over 10 minutes. The common treatments of patients will not be stopped. 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. 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. Motamed Cancer Institute Modiriat Atiye Bahman Company Cell therapy budget of the Islamic Consultative Assembly Approved 2020-05-06 Research Ethics Committee of Motamed Cancer Institute Academic Center for Education Culture and Rese No 146, South Ghandi, Vanaq Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)