Stroke. Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
Conditions
Interventions
intravenous (IV) and intra-arterial (IA) autologous bone marrow mononuclear cells (BM-MNCs) in stroke patient..
Treatment - Other
intravenous (IV) and intra-arterial (IA) autologous bone marrow mononuclear cells (BM-MNCs) in stroke patient.
Sponsors
Vice chancellor for research, Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: age range 30–80 years old; time of stroke onset known and treatment could be started within 7 days of onset. If the exact time of stroke is unknown when the symptoms of stroke have been observed to last referred; NIHSS score 8 to20; CT and MRI images can approve stroke; negative pregnancy test in women who are of childbearing age; stroke confined to MCA territory on CT or MRI brain scan; all the study steps detailed to the patient and if the patient's consciousness the patient's relatives have to be explained; signed informed consent if the patient is unable to provide meaningful consent their guardian or legal representative must give their consent to participate by signing the informed consent document. Exclusion criteria: evidence on neuroimaging (CT or MRI) of a brain tumor, cerebral edema with mid line shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction, and intraventricular, intracerebral, or subarachnoid hemorrhage; people who have difficulty accessing them in the future; patients with evidence of life-threatening infection including (AIDS, hepatitis and cancer); renal dysfunction with creatinine .150 mmol/l; before the stroke alone is not able to perform their daily activities; blood glucose levels is not less than 3 mmol or more than 20 mmol; female patients of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding; patients who are participating in another clinical trial; current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to the study requirements.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score of NIHSS scale. Timepoint: On 2-24 hours,7days,1-3-6-12 month after cell injection. Method of measurement: NIHSS questionnaire (0-42) score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Create Rebleeding. Timepoint: On 2-24 hours, 7days, 1, 3, 6 and 12 months after cell injection. Method of measurement: MRI of brain.;MRS score. Timepoint: On 2-24 hours, 7days, 1, 3, 6 and 12 months after cell injection. Method of measurement: MRS questionnair with score 0-6.;Rate of Epilepsy. Timepoint: On 24 hours and 7 days after cell injection. Method of measurement: EEG.;Evaluation of structural brain by MRI. Timepoint: On 2-24 hours, 7 days, 1, 3, 6 and 12 month after cell injection. Method of measurement: Results of volume of infarction and lateral ventricles before and after cell injection by MRI. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Amir Hosseini
Iran University of Medical Sciences
Outcome results
None listed