Evaluation of safety of mitochondrial transplantation extracted from platelets in brain ischemic stroke: Clinical trial Phase I

Rasht University of Medical Sciences0 个研究点目标入组 10 人开始时间: 待定最近更新: 2021年2月22日

适应症

试验速览

暂无简介。

•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.

•- 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.
•-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

发起方

Rasht University of Medical Sciences