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IRCT20180619040147N7 IRCT 2021-08-12 Iranian academic center for education culture and research Treatment of Covid-19 using menstrual blood stem cell secretome Efficacy study of allogeneic human menstrual blood stem cells secretome to treat moderate to severe Covid-19 patients, clinical trial phase III 2021-07-23 anticipated 90 Complete https://irct.ir/trial/57961 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple computer-aid randomization method is used. In this method, a list of numbers from 1 to 90 is prepared, and each number is randomly assigned to groups A or B by a computer. Depending on the time of hospitalization, these numbers are assigned to the patients, respectively, and based on the list of patients, they are assigned to intervention group A (routine treatment with cell therapy) and control group B (routine treatment with normal saline injection). So that in each group there are 45 patients, Blinding description: This study is a double-blind trial ( participants and data and outcome assessors). Because the drug is in the form of a stem cell supernatant cultured in a phenol-free culture medium, this medium is similar in color and volume to a normal saline injection serum, and therefore at the time of injection, The patient will not notice any difference in the color or volume of the medicine. The data analyst will also not know which of the drug/placebo options each patient receives and is unaware of the nature of the codes assigned to patients. 3 moderate to severe covid-19 patients. Intervention 1: Intervention group: patients are treated by intravenous injection of 5 times supernatant culture medium of allogeneic menstrual blood-derived stem cells. After isolation and culture in a cleanroom under the GMP of Sina Eltiam Biomedical Engineering Company GMP and passing and quality control tests, stem cells are stored in the cell bank. After cell thawing and culture in a GMP-approved culture medium, this surface culture medium is collected and centrifuged to remove cells and cell debris, and after filtration, quality control tests are performed on the collected culture medium. The 5 ml cell secretion is then filled into sterile vials and packaged. Each vial dissolved in 100 ml of normal saline is injected through a peripheral vein over a period of 60 minutes. Intervention 2: Control group: in addition to receiving routine national treatments for this disease, 45 patients undergo intravenous injection of 100 ml of normal saline 5 times in completely similar conditions to the intervention group. 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 more information
public علی دهقان منشادی
Dr. Gharib Streetَ, At the end of Keshavarz Blvd, Imam Khomeini Hospital Complex
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 0000 Sealdema@yahoo.com Tehran University of Medical Sciences scientific Somaieh Kazemnejad
Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1936773493 +98 21 2243 2020 kazemnejad_s@yahoo.com Iranian academic center for education culture and research Iran (Islamic Republic of) Aged 40-65 years Voluntarily participate in this clinical trial and sign off "informed consent form" Chest imaging confirm COVID-19 featured lesions in the lung The SARS-CoV-2 nucleic acid test was positive Diagnosed with severe pneumonia of COVID-19: respiratory distress, Respiratory rate (RR) ≥ 30 times/min; resting oxygen saturation of 90% or less; arterial pressure of oxygen/the fraction of inspired oxygen≤ 300 mmHg; pulmonary imaging of focus within 24-48 hours > 50% progression Patients with a diagnosis of moderate pneumonia caused by Covid-19: 1- Presence of respiratory symptoms (including shortness of breath, feeling of pain and pressure in the chest, ...) with or without fever equal to / greater than 38 ° C 2- Percentage of blood oxygen saturation in Room air at rest between 90 to 93% 3-Pulmonary infiltration less than 50% 20 years 75 years Both History of drug reactions or allergies Pneumonia caused by bacteria, Mycoplasma, Chlamydia, Legionella, fungi, or other viruses Airway obstruction due to lung cancer or unknown factors Carcinoid syndrome History of epilepsy and long-term use of anticonvulsant drugs during the last 3 years History of long-term use of immunosuppressive drugs History of chronic respiratory illness that requires long-term oxygen therapy The patient is on blood or peritoneal dialysis Creatinine clearance <15 ml / min Moderate to severe liver disease (Child-Pugh score> 12) History of deep vein thrombosis (DVT) or pulmonary embolism over the past 3 years Being under ECMO or high-frequency oscillatory ventilation support Diagnostic of HIV, hepatitis B, and syphilis Pregnant or lactating women Lack of consciousness and inability to provide informed consent by the patient U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: patients are treated by intravenous injection of 5 times supernatant culture medium of allogeneic menstrual blood-derived stem cells. After isolation and culture in a cleanroom under the GMP of Sina Eltiam Biomedical Engineering Company GMP and passing and quality control tests, stem cells are stored in the cell bank. After cell thawing and culture in a GMP-approved culture medium, this surface culture medium is collected and centrifuged to remove cells and cell debris, and after filtration, quality control tests are performed on the collected culture medium. The 5 ml cell secretion is then filled into sterile vials and packaged. Each vial dissolved in 100 ml of normal saline is injected through a peripheral vein over a period of 60 minutes. Control group: in addition to receiving routine national treatments for this disease, 45 patients undergo intravenous injection of 100 ml of normal saline 5 times in completely similar conditions to the intervention group Decrease in serum CRP levels. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation. Decrease in serum levels of lactate dehydrogenase. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation. Decrease in serum D-Dimer levels. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation. Decrease in lymphopenia percentage. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation. Reduce the size of the lesion on CT scan of the lungs. Timepoint: En On days 0, 10, 28 after the first intervention. Method of measurement: CT Scan. Improving respiratory efficiency. Timepoint: Before the intervention until the one month after the first intervention on a daily basis. Method of measurement: Measuring PaO2 / FiO2 ratio or percentage of blood oxygenation. Increasing the number of patients weaning from mechanical ventilation. Timepoint: Daily for one month after the first injection. Method of measurement: Observation. Reduce the number of days hospitalized in the ICU. Timepoint: Daily for one month after the first injection. Method of measurement: Observation. Reducing the incidence of failure of various organs. Timepoint: Daily for one month after the first injection. Method of measurement: Observation. Reduce mortality rate. Timepoint: Daily for one month after the first injection. Method of measurement: Counting people. Iranian academic center for education culture and research Approved 2021-07-19 Research Ethics Committees of Avicenna Research Institute Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)