Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.

Detailed Description
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Stroke is among the main causes of mortality and disability of elderly population which still lack of efficient therapy. Stem sell transplantation provides a functional improvement after cerebral ischemia in rat models. Our study will recruit 40 ischemic stroke patients which will be divided into 2 groups (20 patients each): treatment group and control group. The former will be implanted with peripheral blood stem cell through anterior cerebral artery or middle cerebral artery (determined by the section of infarction) and receive convention stroke therapy. The latter only receive convention stroke therapy. The investigators expect that transplantation of the peripheral hematopoietic stem cell is safe and efficient to neurological recovery.

Official Title
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Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Procedure: autologous hematopoiesis stem cell transplantation
* Drug: Aspirin
* Drug: Warfarin
* Drug: Atorvastatin
* Drug: Edaravone
* Drug: Aspirin
* Drug: Warfarin
* Drug: Atorvastatin
* Drug: Edaravone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 40 70 no consciousness disorders internal carotid artery territory infarction stroke happened < 1 year with stable hemiplegia, but remain dependent in daily life SSS(Scandinavian Stroke Scale) < 40 Exclusion Criteria: pregnant women can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- | --- |
| Experimental: cell transplantation<br>The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy. | Procedure: autologous hematopoiesis stem cell transplantation<br>* Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.<br>Drug: Aspirin<br>* aspirin 100mg,qd,po(patients with no fibrillation atrial)<br>Drug: Warfarin<br>* warfarin 2 6mg,qd,po(patients with fibrillation atrial);<br>Drug: Atorvastatin<br>* atorvastatin 20mg,qd,po<br>Drug: Edaravone<br>* edaravone 30mg,bid,ivgtt.<br>|
| No Intervention: Convention therapy<br>The control group just receive drug therapy. | Drug: Aspirin<br>* aspirin 100mg,qd,po(patients with no fibrillation atrial)<br>Drug: Warfarin<br>* warfarin 2 6mg,qd,po(patients with fibrillation atrial)<br>Drug: Atorvastatin<br>* atorvastatin 20mg,qd,po<br>Drug: Edaravone<br>* edaravone 30mg,bid,ivgtt<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in NIH-stroke scale (NIHSS) at 12 months |  | 1,3,6,12 months after cell transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel index |  | 1,3,6,12 months after cell transplantation | 
| perfusion magnetic resonance imaging scan |  | 1,3,6,12 months after cell transplantation | 
| Modified Rankin Scale(mRS) |  | 3,6,12 months after cell transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, hematopoietic stem cell transplantation