Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Other: HUCB monocyte cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age of Subjects between 45 through 80 years. Acute Ischemic Stroke. National Institutes of Health Stroke Scale (NIHSS):6-18 Brain MRI shows the middle cerebral artery region (M1 and M2) of cerebral i infarction stroke patients. Subjects have no midline shift or hemorrhagic transformation Exclusion Criteria: NIHSS score reduced more than 4 within after 24 hours. Female are pregnant or lactating. Subjects with impaired liver function, AIDS, cancer or other significant medical condition (including certifiable diseases, rare disease) Subjects joined other clinical trails or received rt-PA therapy. Immune dysfunction or receiving other immunosuppressive agents. Subjects cannot have MRI test Subjects' HLA typing results match less than 4 out of the 6 genotypes

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: acute ischemic stroke
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HUCB monocyte cells w/ Mannitol in acute ischemic stroke<br>The cord blood need to be infusion within less than 10 days after the onset of stroke, with the cord blood mononuclear cells 200 million   500 million will used. 20% mannitol 200 ml iv for 30±10 min/q8h±2h will be administered twice after cord blood infusion . | Other: HUCB monocyte cells<br>* 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. 20% mannitol 200 ml iv for 30±10 min/q8h±2h will be administered twice after cord blood infusion .<br>* Other names: 20% Mannnitol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, umbilical cord blood