Effect of intravenous (IV) and intra-arterial (IA) autologous bone marrow mononuclear cells (BM-MNCs) in stroke patients.

Phase 1

• Conditions: Stroke.; Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries

• Registration Number: IRCT2017092527865N3
• Lead Sponsor: Vice chancellor for research, Iran 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 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 4

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.