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IRCT20200413047063N1 IRCT 2020-05-04 Execution of Imam Khomeini's Order Placental Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection: A Phase 1-2 Clinical Trial Placental Mesenchymal Stem cells for treatment of ARDS in Coronavirus infection, Phase 1 and 2 Clinical Trials 2020-03-20 anticipated 20 Complete https://irct.ir/trial/47156 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were randomly divided into two equal groups using a randomized double AB blocking method based on a random number table. 1-2 Acute Respiratory Distress Syndrome of COVID-19. Intervention 1: Intervention group:Intervention group: The intervention group 1, Patients will receive three doses of MSCs. Two doses of 100×10e6 (±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 and day 2 and day 4. Intervention 2: Control group:Patients will receive conventional therapy. 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: e-Mail How to obtain: 1-2 months after request Comments:
public Masoud Soleimani
Jalal - al- Ahmad-Chamran High way
Tehran Iran (Islamic Republic of) 1415533122 +98 21 8288 0000 soleim_m@modares.ac.ir Tarbiat Modares University scientific Mohammad Vasei
Shariati Hospital
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 mvasei@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Confirmation of 2019-nCoV infection by RT-PCR Diagnosis of ARDS according to the Berlin definition of ARDS Requiring supplemental oxygen, PaO2/oxygen absorption concentration (FiO2) ≤ 300MMHG Pulmonary imaging shows that the focused progress > 50% in 24-48 hours Mild to Moderate 2019-nCoV pneumonia/ stay in the ICU <48 hours SOFA score between 2-3 point Pneumonia that is judged by chest radiograph or CT 18 years 65 years Both Severe allergies or allergies after 1st injection to stem cell preparations and their components Patients with a malignant tumor, other serious systemic diseases, and psychosis Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus Patients with previous history of pulmonary embolism Liver or kidney SOFA score of more than 3 points; combined with other organ failure (need organ support), Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30) Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia Continuous use of immunosuppressive agents or organ transplants in the past 6 months In vitro life support (ECMO, ECCO2R, RRT) Pregnant or lactating women Uncontrolled underlying disease Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections) U07.1 COVID-19 Treatment - Other Treatment - Other Intervention group:Intervention group: The intervention group 1, Patients will receive three doses of MSCs. Two doses of 100×10e6 (±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 and day 2 and day 4. Control group:Patients will receive conventional therapy 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. Biomarkers concentrations in plasma. Timepoint: At baseline, 7, 14, 28 days after the first intervention. Method of measurement: Biochemical examination. Respiratory efficacy. Timepoint: From baseline to day 7. Method of measurement: Evaluated by the increase in PaO2/FiO2 ratio. Intensive care unit-free days. Timepoint: Up to day 8. Method of measurement: Number of day. Change in clinical symptoms. 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 Oghaf Organization and charity Opal Parsian Company Execution of Imam Khomeini's Order National Institute for Medical Research Development Oghaf Organization and charity Opal Parsian Company Approved 2020-03-19 Ethics committee of Tehran University of Medical Sciences Keshavarz Blvd- Qods , TUMS Tehran Tehran Iran (Islamic Republic of)