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The purpose of the study is to determine the safety and possible effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.
The study will use CD34+ 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 5 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. We will isolate CD34 cells from these units, purified them, suspend the cells in solution (1 ml containing 2-8 million cells), and inject the cells into brain around the site damaged by the stroke
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HUCB, Medicine, Rehabilitation | Experimental | Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intercerebral implantation of allogenic CD34+ stem cell | Procedure | Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in NIH Stroke Scale (NIHSS) | Evaluate change from Baseline in NIHSS at 1 week | Change from baseline in NIHSS at 1 weeks |
| Change from Baseline in NIH Stroke Scale(NIHSS) | Evaluate change from Baseline in NIHSS at 2 weeks | Change from Baseline in NIHSS at 2 weeks |
| Change from baseline in NIH Stroke Scale | Evaluate change from baseline in NIHSS at 4 weeks | Change from baseline in NIHSS at 4 weeks |
| Change from baseline in NIH Stroke Scale ( NIHSS) | Evaluate change from baseline in NIHSS at 12 weeks | Change from baseline in NIHSS at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Brain Image | Brain Image will be performed by MRI. The MRI evaluation includes DEI, T1W, T2W, MRS, and DTI, and change from baseline will be evaluated at 1 week | Change from baseline in Brain Image at 1 week |
| Change from baseline in Brain Image |
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Inclusion Criteria:
Exclusion Criteria:
Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory.
Pregnant or lactating women.
History of alcohol or drug abuse in the previous 3 months.
Subjects must not have the following conditions in documents:
Subject must not be currently participating in another investigational study or taking any investigational drug within the last four weeks before the screening of this study.
Any other condition that, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and would not be suitable to perform a surgery or to participate in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Woei-Cherng Shyu, M.D.;PhD. | Contact | 886-4-22052121 | 7813 | Shyu9423@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shinn-Zong Lin, M.D.;PhD. | China Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | Taiwan | 244 | Taiwan |
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Brain Image will be performed by MRI. The MRI evaluation includes DEI,T1W,T2W,MRS and DTI , and evaluate the change from baseline at 4 weeks |
| Change from baseline in Brain Image at 4 weeks |
| Change from baseline in Brain Image | Brain Image will be performed by MRI.MRI image includes DEI,T1W, T2W, and DTI, and change from baseline will be evaluated at 6 months. | Change from baseline in Brain Image at 6 months |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020244 | Infarction, Middle Cerebral Artery |
| D007511 | Ischemia |
| D002545 | Brain Ischemia |
| D020521 | Stroke |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002544 | Cerebral Infarction |
| D020520 | Brain Infarction |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D007238 | Infarction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D036101 | Cord Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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