Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Autologous Peripheral Blood CD34 Stem Cell Implantation in Chronic Stroke Patients

Conditions
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Stroke, Middle Cerebral Artery Infarction

Intervention / Treatment
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* Procedure: Intercerebral implantation of Autulogous Stem Cells
* Drug: convention therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 35-70 chronic stroke adult patient, with stroke history of more than 6 months, less than 60 months， with stable hemiplegia condition, and NIHSS (NIH Stroke Scale) score is between 9-20. Exclusion Criteria: patients aged less than 35 or more than 70, hemorrhage stroke or MRI show the occlusion is not in the middle cerebral artery territory，NIHSS is not in the range of 9-20, pregnant women, impaired liver function, abnormal blood coagulation, AIDS, combine other tumor or special condition.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PBSC Treatment<br>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 | Procedure: Intercerebral implantation of Autulogous Stem Cells<br>* 2-8 millions Stem cell per patients plus convention therapy<br>* Other names: CD34 Stem Cell;|
| Active Comparator: Control<br>Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication | Drug: convention therapy<br>* antiplatelet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH-stroke scale (NIHSS) |  | 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Stem Cell, Cell Therapy, CD34 Stem cell, Peripheral blood Stem cell