Acute Ischemic Stroke
Conditions
Keywords
acute ischemic stroke, umbilical cord blood
Brief summary
The objective of the study is to determine the safely of Human Umbilical Cord Blood mononuclear cells by Intravenous injection in acute ischemic stroke patients.
Detailed description
The study will use Umbilical Cord Blood cells (a special kind of cell that is believed to be a stem cell) isolated from UCB (blood obtained at birth from the umbilical cord blood of babies). StemCyte, a leading accredited UCB banking company with branches in the United States and Taiwan, will provide the units of UCB that match at least 4 out of 6 HLA (human leukocyte antigens) for transplantation. The HLA-matching is the same as that used to match cells and organs for transplantation so that the body does not reject the cells. Then cells injection by Intravenous in acute ischemic stroke patients.
Interventions
OTHERhUCB
1. The cord blood need to be infusion within less than 10 days after the onset of stroke, and the cord blood mononuclear cells 200 million \ 500 million will used. 2. 20% mannitol 200 ml iv for 30±10 min/q8h±2h will be administered twice after cord blood infusion .
Sponsors
Buddhist Tzu Chi General Hospital
StemCyte Taiwan Co., Ltd.
China Medical University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
acute ischemic stroke
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The age of Subjects between 45 through 80 years. 2. Acute Ischemic Stroke. 3. National Institutes of Health Stroke Scale (NIHSS):6-18 4. Brain MRI shows the middle cerebral artery region (M1 and M2) of cerebral i infarction stroke patients. 5. Subjects have no midline shift or hemorrhagic transformation
Exclusion criteria
1. NIHSS score reduced more than 4 within after 24 hours. 2. Female are pregnant or lactating. 3. Subjects with impaired liver function, AIDS, cancer or other significant medical condition (including certifiable diseases, rare disease) 4. Subjects joined other clinical trails or received rt-PA therapy. 5. Immune dysfunction or receiving other immunosuppressive agents. 6. Subjects cannot have MRI test 7. Subjects' HLA typing results match less than 4 out of the 6 genotypes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse events (AE)and serious adverse reaction(SAE) | after infusion 24, 48, 72 hours , 1 week or discharge , and 1, 3, 6 , 9, 12 months. | any AE or SAE (related or non-related) during the 12-month follow-up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood examination | baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months | physical condition monitoring |
| cytokine family | baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months | for study |
| Brain Image(MRI) | baseline, after infusion 24 hours, 1, 6, 12months | changes of Brain Images |
| Barthel Index | baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months | neurology function changes |
| NIHSS | baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months | neurology functions change |
| Berg Balance score | baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months | motor function changes |
| abdominal sonography-spleen | baseline, after infusion 24, 72 hours, 3, 12months | size changes of spleen |
Countries
Taiwan
Outcome results
None listed