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| Name | Class |
|---|---|
| Buddhist Tzu Chi General Hospital | OTHER |
| StemCyte Taiwan Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hUCB w/ Mannitol in acute ischemic stroke | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hUCB | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| adverse events (AE)and serious adverse reaction(SAE) | any AE or SAE (related or non-related) during the 12-month follow-up period | after infusion 24, 48, 72 hours , 1 week or discharge , and 1, 3, 6 , 9, 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Image(MRI) | changes of Brain Images | baseline, after infusion 24 hours, 1, 6, 12months |
| abdominal sonography-spleen | size changes of spleen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shinn-Zong Lin, M.D.;PhD. | Buddhist Tzu Chi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hualien Tzu Chi Hospital | Hualien City | Taiwan | 707 | Taiwan |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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acute ischemic stroke
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| baseline, after infusion 24, 72 hours, 3, 12months |
| NIHSS | neurology functions change | baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months |
| Berg Balance score | motor function changes | baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months |
| Barthel Index | neurology function changes | baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months |
| Blood examination | physical condition monitoring | baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months |
| cytokine family | for study | baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |