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IRCT20210212050334N1 IRCT 2021-02-16 Rasht University of Medical Sciences Evaluation of safety of mitochondrial transplantation extracted from platelets in brain ischemic stroke: Clinical trial Phase I Evaluation of safety of mitochondrial transplantation extracted from platelets in brain ischemic stroke: Clinical trial Phase I 2021-04-03 anticipated 10 Complete https://irct.ir/trial/54272 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization is used for randomization. The Quadruple blocks are used and the ratio is 1: 1. Blocking is not done through software and is done manually. Sequences are marked in closed envelopes with the letters A and B in which the letter A is allocated for intervention group and letter B is allocated for control group. In this randomization, blindness is also determined and only the person who is responsible for the extraction of mitochondria will be responsible for doing the work, Blinding description: Patients know that they are going to be involve in a project. Participants who completed the informed consent are two groups of control and intervention who are blinded to with mitochondria or buffer. The principal investigator and the treating physician and all those who interact with the patient in some way are blinded like the nurses. Those who analyze the data are also blinded. The Data Safety and Monitoring Committee and those who analyze the outcome are also blinded. The only person who is not blinded is the one who extracts the mitochondria. The draft article will be written after the completion of the project as well as obtaining all the results and data. The author of the draft article is the main researcher who has been blinded from the beginning. 1 Brain ischemia. Intervention 1: Intervention group: The product that is going to be transplanted is mitochondria. Patients will receive approximately 500,000 platelet-derived mitochondria intravenously three times at one-hour intervals. Intervention 2: Control group: In this group only the respiration buffer is injected. Yes - There is a plan to make this available What will be shared: Age, sex, mortality rate, cancer incidence, bleeding and side effects When: After publishing of the results in the journal To whom: Universities Conditions: Only for studying not for analysis Where to obtain: Amaneh Mohammadi Roushandeh dinachal@yahoo.com How to obtain: The application must be written to the Deputy of Research and technology of Guilan University of Medical Sciences. From there, the request is sent to the principle investigator and the researcher sends the documents to the deputy. The applicant can receive the documents from the deputy. Comments:
public Amaneh Mohammadi Roushandeh
Anatomical Sciences department, Medicine faculty, Guilan University of Medical Sciences, rasht, Guilan
Rasht Iran (Islamic Republic of) 4144666949 +98 13 3333 5820 mohammadi_roushandeh@gums.ac.ir Rasht University of Medical Sciences scientific Mehryar Habibi Roudkenar
Burn and regenerative medicine research center, Velayat hospital, Rasht, Guilan
Rasht Iran (Islamic Republic of) 4144666949 +98 13 3333 5820 mhr376@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) -Patients who have recently had a stroke and have not had a stroke for more than 24 hours are selected . .-Patients from both sexes and over 40 years are selected. -Patients who able to fill the informed consent of the research project. The text of the consent form with full explanation of the nature and purpose of this study must be signed by the patient or their supervisor or legal representative. For example, if a patient fails to sign a consent form in case of confusion or loss of consciousness, it is the responsibility of a close relative Negative pregnancy test for women who are at reproductive age. -- Clinical diagnosis of stroke in patients using computed tomography (CT) or magnetic resonance imaging Brain MRI + DWI (MRI) show acute ischemia in the right middle cerebral artery. - Patients are evaluated and scored according to the National Stroke Institute (NIHSS) scale. Accordingly, patients who get a score of 8 to 20 on this scale will be selected. 41 years no limit Both - Patients with mitochondrial disorders. -Patients who are in a coma and have score 1 or 2 according to the NIHSS criteria to assess the level of consciousness. -Aphasia -Imaging of patients' brain using CT scan and MRI that may show signs of tumor, cerebral edema, increased intraventricular pressure, intracerebral hemorrhage, or cerebral infarction. -Patients who currently have and/ or had a history of drug or alcohol abuse are excluded from the study. -Patients with active infectious diseases, including HIV, hepatitis B and C, are excluded from the study. -Patients with dementia. -Patients participating in another clinical trial. Any specific clinical conditions or health conditions, such as decreased life expectancy, or multiple illnesses at the same time, or other conditions that prevent proper diagnosis, treatment, or follow up of the disease in the testing process, are excluded from the study. -Inability or unwillingness of the individual or legal guardian / representative to provide informed written consent Patients who do not able to collaborate for follow up I63 Cerebral infarction Treatment - Other Placebo Intervention group: The product that is going to be transplanted is mitochondria. Patients will receive approximately 500,000 platelet-derived mitochondria intravenously three times at one-hour intervals. Control group: In this group only the respiration buffer is injected. Mortality rate. Timepoint: 24hour, one week, six months, one year. Method of measurement: The death rate is indicated by a number. - Systemic and adverse Side effects after 24, one week and six months and one year. Timepoint: 24hour, one week, six months, one year. Method of measurement: Barometer, EKG, NIHSS. Brain Bleeding. Timepoint: 24hour, one week, six months, one year. Method of measurement: National Institutes of Health stroke scale score, MRI. Cancer incidence. Timepoint: Six months , one year. Method of measurement: MRI. Rasht University of Medical Sciences Approved 2021-02-07 Ethic committee of Guilan University of Medical Sciences Anatomical Sciences Department, Medicine faculty, Guilan University of Medical Sciences, Rasht, Guilan Rasht Guilan Iran (Islamic Republic of)