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IRCT20141224020427N4 IRCT 2020-11-11 Shahid Beheshti University of Medical Sciences Exosome Therapy in Stroke Safety of allogenic mesenchymal stem cells derived exosome on disability of patients with acute ischaemic stroke: a randomised, open labled, placebo-controlled, phase 1 trial 2020-11-09 anticipated 5 Complete https://irct.ir/trial/51830 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Ischemic Stroke. Allogenic Mesenchymal stem cell derived Exosome injection locally in ischemic region under decompress surgery in patient with acute ischemic stroke. The exosome concentration is 200Mg/ml and patients receive one dose for one time. Yes - There is a plan to make this available What will be shared: The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles When: The non-identifiable individual participant data will become available after the publication of the relevant articles To whom: The non-identifiable individual participant data will become available to other researchers in academic institutions Conditions: The non-identifiable individual participant data can only be used for research Where to obtain: The non-identifiable individual participant data will be obtainable by sending an e-mail to Prof.Masoud Soleimani (Email: Soleimani.masoud@gamil.com) How to obtain: Other researchers in academic institutions can send their request by e-mail to Prof.Masoud Soleimani (Email: Soleimani.masoud@gamil.com). The data will be sent to them after consulting and approving the research team Comments:
public Saeed Oraee Yazdani
Tajrish Hospital, tajrish squ
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 saeed_o_yazdani@yahoo.com Shahid Beheshti University of Medical Sciences scientific Masoud Soleimani
Velenjak, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 9847 soleimani.masoud@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Male acute ischemic patients aged 40-80 years with symptoms of acute cerebral infarction of less than 24h from stroke onset. Patients with a measurable focal neurological that must persist to the time of treatment without clinically meaningful improvement Patients must have computerized tomography (CT) and / or magnetic resonance imaging (MRI) compatible with the clinical diagnosis of acute ischemic stroke in the territory of the middle cerebral artery before being included in the study. Patients must have a score on the NIH Stroke Scale 8-24, Obtaining informed consent signed 40 years 80 years Male Comatose patients. brain tumour, cerebral oedema with compression of ventricles, cerebellar infarction or brainstem, or intraventricular, intracerebral or subarachnoid haemorrhage. alcohol use Active infectious disease, including HIV, hepatitis B, Hepatitis patients with dementia Specify clinical conditions Patients who are participating in another clinical trial. Inability or unwillingness of individual for giving written informed consent. G46.4 Cerebellar stroke syndrome Treatment - Other Allogenic Mesenchymal stem cell derived Exosome injection locally in ischemic region under decompress surgery in patient with acute ischemic stroke. The exosome concentration is 200Mg/ml and patients receive one dose for one time Fever. Timepoint: 3, 30 and 90 days after injection. Method of measurement: Thermometer. High sensitivity C-Reactive protein. Timepoint: 3, 30, 90 days after injection. Method of measurement: Colorimetric Method. Recurrent Stroke. Timepoint: 3, 30, 90 days after injection. Method of measurement: computerized tomography (CT). Hemorrhagic transformation. Timepoint: 3, 30, 90 days after injection. Method of measurement: computerized tomography (CT). Brain Oedema. Timepoint: 3, 30 , 90 days after injection. Method of measurement: computerized tomography (CT). NCT03384433 ClinicalTrials.gov Shahid Beheshti University of Medical Sciences Approved 2019-07-20 Shahid Beheshti University of Medical Sciences Velenjak Tehran Tehran Iran (Islamic Republic of)