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IRCT20201202049568N3 IRCT 2021-03-05 Tarmim Ava Baran Knowledge Based Company Exosome therapy in ARDS patients Evaluation of the Safety and Efficiency of human Umbilical Cord Derived Mesenchymal Stem Cell Exosomes in patients with ARDS of COVID-19; An interventional randomized double-blind controlled clinical trial: phase I and II 2021-03-05 anticipated 72 Complete https://irct.ir/trial/54758 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the Stratified Block Randomization method is used to randomize patients in the intervention and control groups. Because patients with different intensities are in the study, classification is based on the type of need or lack of need for respiratory support. Patients who need respiratory support in the form of mechanical ventilation are classified in group A and patients who need nasal cannula or do not need respiratory support are classified in group B. The blocks used are of sizes 2, 4, and 8, and based on the probable number of people participating in the study with any severity of the disease, blocks with the appropriate volume are used to generate random codes. In order to place patients in control and intervention groups, a random sequence table is created with the help of SAS 9.1 software. Each patient is assigned a completely random sequence number, and random numbers are placed in envelopes (exactly the same, completely closed, with no transparency to view the contents of the envelope). Patients choose one of the envelopes as they wish. Envelopes are kept by a researcher, who does not participate in the study and is not aware of the type of study until the data is collected. Only in case of severe complications, the researcher will be notified through the main project partner to open the relevant envelope, Blinding description: In this study, the participant in the intervention, his / her clinical caregiver, trial researcher, and outcome assessor did not know that they were prescribing the intervention drug or placebo. 1-2 Acute Respiratory Distress Syndrome due to COVID-19. Intervention 1: Intervention group: Phase one: 12 patients with COVID-19 in two groups of 6 with ARDS (each group includes intervention groups of 3). Phase Two: 60 patients with COVID-19-ARDS in two groups of 30 controls and intervention. Classified A and B in both control and intervention groups - Exosome receiving group (intervention groups) • Injection material: Umbilical Cord Stem Cell-derived exosomes• Injection rate: 100 million exosomes per kilogram of body weight • Injection carrier: Saline • Injection site: Intravenous. Intervention 2: Control group: Conventional treatments used in ARDS. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after the patient turned Unidentifiable. When: Access period starts 6 months after the results are published To whom: All people Conditions: Physicians and people working in the regenerative medicine industry Where to obtain: The person is responsible for the scientific content of the clinical trial. Dr. Alireza Shoae Hassani cell.therapy@yahoo.com How to obtain: The scientific supervisor of the trial transmits the request to the sponsor and with his permission provides the documents to the applicant. Comments:
public Rashin Mohseni
Pediatric Cell Therapy Research Center, Children's Medical Center Hospital, Gharib Ave, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6694 8444 rashin_mohseni@yahoo.com Tehran University of Medical Sciences scientific Alireza Shoae Hassani
Stem Cell and Regenerative Medicine Research center, Motahari hospital, Rashid Yasemi Ave., Valiasr Ave.
Tehran Iran (Islamic Republic of) 1996835929 +98 21 8877 0031 cell.therapy@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Acute respiratory distress Syndrome of moderate to severe type (PaO2/ FiO2 <200mmHg) Age range between 18 to 65 years Men and Women No participation in another clinical trial during this study Patients who have given themselves and their families a full explanation of the study process and have obtained informed written consent Chest X-ray showed bilateral infiltration with pulmonary edema Definitive infection with COVID-19 confirmed by PCR 18 years 65 years Both Cancer or malignant diseases Pregnant women or planning to become pregnant Inflammatory diseases Symptoms or history of liver or kidney failure History of lung surgery or Lung transplantation Having an autoimmune disease Metabolic disorders (such as diabetes) Infectious viral infection Proven blood clotting disorders Participate in other clinical trials simultaneously Severe trauma occurred within 14 days before screening They are undergoing hemodialysis or peritoneal dialysis Bone marrow transplantation Have a history of epilepsy, need continuous anticonvulsant therapy U07.1 Acute respiratory distress syndrome Treatment - Other Treatment - Other Intervention group: Phase one: 12 patients with COVID-19 in two groups of 6 with ARDS (each group includes intervention groups of 3). Phase Two: 60 patients with COVID-19-ARDS in two groups of 30 controls and intervention. Classified A and B in both control and intervention groups - Exosome receiving group (intervention groups) • Injection material: Umbilical Cord Stem Cell-derived exosomes• Injection rate: 100 million exosomes per kilogram of body weight • Injection carrier: Saline • Injection site: Intravenous Control group: Conventional treatments used in ARDS Adverse reaction (AE) and severe adverse reaction (SAE). Timepoint: At the beginning of the intervention and on days 2, 3, 4, 7 and 14 after the intervention. Method of measurement: Physical examination of pulmonary function test. Murray lung injury score. Timepoint: Baseline and Days 1, 2, 3, 7, 14, 28, and 60 after intervention. Method of measurement: Clinical checklist. The minimum value is 0 and the maximum is 16. Higher scores mean a worse outcome. PaO2/FiO2. Timepoint: Baseline and Day 3, Day7, Day14, Day28, Day60. Method of measurement: Oxygen index: the ratio of alveolar oxygen partial pressure to fraction of inspired oxygen. The number of days the survivor was out of ICU. Timepoint: 60 Days. Method of measurement: The number of days the survivor was out of ICU. Blood biochemistry (CRP). Timepoint: Baseline, day 5, 10, 20. Method of measurement: C-reactive protein (CRP, mg/mL) concentration in the plasma will be measured. Tarmim Ava Baran Knowledge Based Company Approved 2020-11-21 Ethics committee of Tehran University of Medical Sciences Children's Medical Center Hospital, Dr. Gharib Ave, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)