Middle Cerebral Artery Infarction, Stroke
Conditions
Keywords
Stroke, Stem Cell, Cell Therapy, CD34 Stem cell, Peripheral blood Stem cell
Brief summary
The objective of the study is to determine the efficacy of brain transplants of CD34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.
Detailed description
30 patients are divided into 2 groups, one treatment group and one control group.Treatment group will be implanted with peripheral blood stem cell and receive convention stroke therapy ,and control group only receive convention stroke therapy. We expect that transplantation of the peripheral blood CD34+ cells has the potential of significant benefit to neurological recovery. In a previous phase I clinical trial, we have shown that transplantation of CD34+ cells obtained from the peripheral blood of the chronic stroke patients was safe and beneficial for neurological recovery. We expect this trial can further prove the efficacy of this treatment method.
Interventions
PROCEDUREIntercerebral implantation of Autulogous Stem Cells
2-8 millions Stem cell per patients plus convention therapy
DRUGconvention therapy
antiplatelet
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* aged 35-70 chronic stroke adult patient, * with stroke history of more than 6 months, less than 60 months， * with stable hemiplegia condition, and * NIHSS (NIH Stroke Scale) score is between 9-20.
Exclusion criteria
* patients aged less than 35 or more than 70, * hemorrhage stroke or MRI show the occlusion is not in the middle cerebral artery territory，NIHSS is not in the range of 9-20, * pregnant women, * impaired liver function, abnormal blood coagulation, AIDS, combine other tumor or special condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NIH-stroke scale (NIHSS) | 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| European stroke scale (ESS) | 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months |
| European stroke motor subscale (EMS) | 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months |
| Barthel index and Mini-Mental State Examination (MMSE) | 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months |
| Magnetic resonance imaging (MRI) and computed tomography (CT) scans | 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months |
Countries
Taiwan
Outcome results
None listed