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IRCT20200426047206N2 IRCT 2020-07-06 Hamedan University of Medical Sciences The efficacy and safety of mesenchymal stem cell transplantation in patients with COVID-19 pneumonia Clinical trial of efficacy and safety of mesenchymal stem cell transplantation in patients with COVID-19 pneumonia 2020-07-22 anticipated 30 Complete https://irct.ir/trial/49385 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, we will use the BalancedBlock Randomization method (block size=4). Random allocation software will be used for this purpose. At first, we prepare two sheets of paper. We write "Intervention" on a paper and "Standard treatment" on another. Mix the sheets together and place them on the desk drawer. With the referral of each of the eligible patients, one of the cards will be drawn randomly and based on this drawn card, it will be assigned to one of the two groups. It should be noted that the drawn sheets will not be returned to the drawer until all four sheets have been removed. After all four sheets are drawn randomly, all the sheets are returned to the drawer and the above operation will be continued for the next four patients until the desired sample size is reached, Blinding description: No information will be provided to clinical caregivers and evaluators about which group got the cell and which one has not taken a cell. 3 COVID-19 disease. Intervention 1: Intervention group: This group receiving mesenchymal stem cells. In this group, patients are received 1 million Umbilical core-derived MSCc/BW by intravenous injection (provided by volunteer donors at Fatemieh Hospital) ( Through the catheter and the Central vein and from the superior vena cava vein ). Also, in addition to cell therapy, Other routine treatments (The last national protocol for COVID-19 treatment) will be given to patients according to the physician's supervision.The umbilical cord will be provided by volunteer donors at Fatemieh Hospital and after that will be cultured and expanded in the cleanroom of Hamadan University of Medical Sciences. Intervention 2: Control group: Receiving routine therapies (The last national protocol for COVID-19 treatment) (without stem cell). 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 There is no further information
public Salman Khazaei
Fahmideh
Hamedan Iran (Islamic Republic of) 6517838695 +98 81 3838 0548 salman.khazaei61@gmail.com Hamedan University of Medical Sciences scientific Salman Khazaei
Fahmideh
Hamedan Iran (Islamic Republic of) 6517838695 +98 81 3838 0548 salman.khazaei61@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Positive PCR test Age between 18-70 years patient with acute respiratory infectious symptoms and severe lung involvement 18 years 70 years Both Sepsis Pregnancy Cancer RA01.0 Severe Acute Respiratory Syndrome coronavirus Treatment - Other Treatment - Drugs Intervention group: This group receiving mesenchymal stem cells. In this group, patients are received 1 million Umbilical core-derived MSCc/BW by intravenous injection (provided by volunteer donors at Fatemieh Hospital) ( Through the catheter and the Central vein and from the superior vena cava vein ). Also, in addition to cell therapy, Other routine treatments (The last national protocol for COVID-19 treatment) will be given to patients according to the physician's supervision.The umbilical cord will be provided by volunteer donors at Fatemieh Hospital and after that will be cultured and expanded in the cleanroom of Hamadan University of Medical Sciences. Control group: Receiving routine therapies (The last national protocol for COVID-19 treatment) (without stem cell) Patient respiratory status. Timepoint: روزانه به مدت دو هفته. Method of measurement: Using CT scan image, physical examination, oxygen saturation percentage. Inflammatory factors. Timepoint: Before and two week after intervention. Method of measurement: Elisa. Hamedan University of Medical Sciences Approved 2020-06-27 Ethics committee of Hamadan University of Medical Sciences Fahmideh Hamadan Hamadan Iran (Islamic Republic of)