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

Phase 1

• Conditions: Brain ischemia.; Cerebral infarction

• Registration Number: IRCT20210212050334N1
• Lead Sponsor: Rasht University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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.

Exclusion Criteria

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.