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IRCT20080901001165N44 IRCT 2020-03-28 Bagheiat-allah University of Medical Sciences A Comparison Study of Repeated Intravenous Infusion of Allogeneic Mesenchymal Stem Cell from Different Sources in ARDS Patients Allo-MSCs-ARDS A Comparison Study on Safety & Efficacy of Repeated Intravenous Infusion of Allogeneic Mesenchymal Stem Cell from Different Sources in ARDS Patients: A Randomized, Double Blind, Clinical Trial Phase II 2020-03-29 anticipated 12 Complete https://irct.ir/trial/46737 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: There are the same cell bags for infusion during study. Clean room staff, DSMB and data statistician just aware of their contain. So, the mentioned people (clinicians for assessment, health care system staff for infusion and patients) will not inform about the type of intervention. 1-2 Acute respiratory distress syndrome (ARDS). Intervention 1: First Intervention group: Wharton's jelly derived mesenchymal stem cells. Intervention 2: Second Intervention group: Amniotic membrane derived mesenchymal stem cells. Intervention 3: Third Intervention group: Bone marrow derived mesenchymal stem cells. Intervention 4: Forth Intervention group: Adipose derived mesenchymal stem cells. Yes - There is a plan to make this available What will be shared: Case Report Form When: Start of access period 6 months after printing results To whom: Researchers working in academic and scientific institutions Conditions: complementary studies related to cell products Where to obtain: Email to corresponding author How to obtain: Reply to email by corresponding author (1 week) After confirmation, data files will be sent less than two weeks Comments:
public Hoda Madani
No. 9, Shaghayegh Deadend, Banihashem St, Resalat Ave, Tehran
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2251 8388 hoda62_m@yahoo.com Iranian academic center for education culture and research scientific Mostafa Ghanei
Mollasadra Ave, after Sheikh Bahaei cross, Vanak square, Tehran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8805 0435 mghaneister@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Signed informed consent voluntarily Confirmed ARDS SOFA score between 2-3 point PaO2/FIO2 ≤ 300 mmHg Mild to Moderate pneumonia/ stay in the ICU <48 hours Pulmonary imaging shows that the focus progress > 50% in 24-48 hours 18 years 65 years Both Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus Liver or kidney SOFA score of more than 3 points; combined with other organ failure Patients with malignant tumor Pregnant or lactating women Uncontrolled underling diseases Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia In vitro life support (ECMO, ECCO2R, RRT) J80 Acute respiratory distress syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs First Intervention group: Wharton's jelly derived mesenchymal stem cells Second Intervention group: Amniotic membrane derived mesenchymal stem cells Third Intervention group: Bone marrow derived mesenchymal stem cells Forth Intervention group: Adipose derived mesenchymal stem cells Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths). Timepoint: Before Intervention, Day 0 (First Intervention) till Day 7, Day 14, Day 28, 3 Moths, 6 Months and 12 months after intervention. Method of measurement: Fill Common Terminology Criteria for Adverse Events (CTCAE) Form. PaO2/FiO2 assessment. Timepoint: Before Intervention, Day 0 (First Intervention) till Day 7, Day 14, Day 28, 3 Moths, 6 Months and 12 months after intervention. Method of measurement: Ventilator. National Institute for Medical Research Development Approved 2020-03-25 National Institute for Medical Research Development No. 21, Besat Ave, West Fatemi Ave, Tehran Tehran Tehran Iran (Islamic Republic of)