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IRCT20200217046526N1 IRCT 2020-04-13 Iranian academic center for education culture and research Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection : A Phase 1 and 2 clinical trial 2020-03-15 anticipated 6 Complete https://irct.ir/trial/47030 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Acute Respiratory Distress Syndrome of COVID-19. 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 infusion speed of 4-5 mL/minute in day 0, day 2, day 4. The cells will inject in 50 ml saline containing 1% human serum albumin.. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD can be shared When: 6 months after publication To whom: Researchers and clinicians Conditions: Planning of similar studies in other academic centers Where to obtain: Email How to obtain: 1-2 months after request Comments:
public Morteza Zarrabi
No. 2, Hafez St., Banihashem St., Resalat Ave
Tehran Iran (Islamic Republic of) 16635148 +98 21 2233 9940 m.zarrabi@rsct.ir Royan Institute scientific Hossein Baharvand
No. 2, Hafez St., Banihashem St., Resalat Ave
Tehran Iran (Islamic Republic of) 16635148 +98 21 2230 6485 hossein.baharvand@gmail.com Royan Institute Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 70 years Both 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 U07.1 COVID-19 Treatment - Other 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 infusion speed of 4-5 mL/minute in day 0, day 2, day 4. The cells will inject in 50 ml saline containing 1% human serum albumin. 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. 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. National Institute for Medical Research Development Iranian academic center for education culture and research National Institute for Medical Research Development Approved 2020-03-12 Ethic committee of National Institute for Medical Research Development No 21, Besat Street., Western Fatimid Street Tehran Tehran Iran (Islamic Republic of)