Cerebral Embolism, Stroke
Conditions
Keywords
stroke, bone marrow, mononuclear cell, angiogenesis, neurogenesis
Brief summary
The purpose of this study is to determine whether autologous bone marrow mononuclear cells transplantation after stroke is safe and/or effective to improve neurological outcome.
Interventions
BIOLOGICALautologous bone marrow mononuclear cells
intravenous administration of autologous bone marrow derived mononuclear cells obtained from 25ml of bone marrow on day 7-10 after stroke (only once in that period)
Sponsors
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
National Cerebral and Cardiovascular Center, Japan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with cerebral embolism. * NIHSS score is more than (or equal to) 10. * On day 7 after onset of stroke, the improvement of NIHSS is less than (or equal to) 5, compared with the level at administration. * Bone marrow aspiration can be done in 10 days after onset of stroke
Exclusion criteria
* Patient with cerebral hemorrhage or symptomatic hemorrhagic infarction. * Patient who expects brain surgery. * Patient with acute myocardial infarction. * Patient with coagulation disorder. * Number of Platelet \< 100000/mm3 * Serum creatinine level \>2.0mg/dl * Patient with malignancy. * Patient with uncontrolled proliferative diabetic retinopathy. * Patient suspected infective endocarditis. * HBV, HCV, HIV or HTLV positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of NIHSS（National Institute of Health Stroke Scale） | 30 days after treatment |
| Frequency of change for the worse in NIHSS | 30 days aftrer treatment |
Secondary
| Measure | Time frame |
|---|---|
| Mean level of mRS (modified Rankin Scale) | 30 days after treatment |
| Frequency of death | day 30 after treatment |
Countries
Japan
Outcome results
None listed