Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether autologous bone marrow mononuclear cells transplantation after stroke is safe and/or effective to improve neurological outcome.

Official Title
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Phase 1/2A Study of Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Patients After Cerebral Embolism

Conditions
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Cerebral Embolism, Stroke

Intervention / Treatment
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* Biological: autologous bone marrow mononuclear cells
* Biological: autologous bone marrow mononuclear cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with cerebral embolism. NIHSS score is more than (or equal to) 10. On day 7 after onset of stroke, the improvement of NIHSS is less than (or equal to) 5, compared with the level at administration. Bone marrow aspiration can be done in 10 days after onset of stroke Exclusion Criteria: Patient with cerebral hemorrhage or symptomatic hemorrhagic infarction. Patient who expects brain surgery. Patient with acute myocardial infarction. Patient with coagulation disorder. Number of Platelet < 100000/mm3 Serum creatinine level >2.0mg/dl Patient with malignancy. Patient with uncontrolled proliferative diabetic retinopathy. Patient suspected infective endocarditis. HBV, HCV, HIV or HTLV positive

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autologous bone marrow mononuclear cell<br>On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously. | Biological: autologous bone marrow mononuclear cells<br>* intravenous administration of autologous bone marrow derived mononuclear cells obtained from 25ml of bone marrow on day 7-10 after stroke (only once in that period)<br>|
| Experimental: autologous bone marrow mononuclear cells<br>On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously. | Biological: autologous bone marrow mononuclear cells<br>* intravenous administration of autologous bone marrow derived mononuclear cells obtained from 50ml of bone marrow on day 7-10 after stroke (only once in that period)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of NIHSS（National Institute of Health Stroke Scale） |  | 30 days after treatment | 
| Frequency of change for the worse in NIHSS |  | 30 days aftrer treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean level of mRS (modified Rankin Scale) |  | 30 days after treatment | 
| Frequency of death |  | day 30 after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, bone marrow, mononuclear cell, angiogenesis, neurogenesis