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| ID | Type | Description | Link |
|---|---|---|---|
| DOH Approval No:098004365 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBSC Treatment | Active Comparator | Patients in PBSC treatment will receive brain implant of autologous peripheral blood stem cell(CD34+) plus convention stroke treatment that include rehabilitation and antiplatelet medication |
|
| Control | Active Comparator | Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intercerebral implantation of Autulogous Stem Cells | Procedure | 2-8 millions Stem cell per patients plus convention therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| NIH-stroke scale (NIHSS) | 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shinn-Zong Lin, MD, DMSci | China Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22163120 | Derived | Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D020244 | Infarction, Middle Cerebral Artery |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| convention therapy | Drug | antiplatelet |
|
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002544 | Cerebral Infarction |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |