Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

Study Overview
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Brief Summary
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Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

Detailed Description
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Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.

Official Title
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Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Genetic: Intravenous stem cell transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-80 chronic ischemia stroke or patients With stroke history of more than 6 months, less than 60 months NIHSS (NIH stroke scale) score of 7 or more points Internal carotid artery territory infarction measured by MRI Can be hospitalized and signed informed consent With fewer effect by traditional post-stroke treatments or rehabilitations Exclusion Criteria: Lacunar infarction Recurrent thrombotic diseases less than 6 months Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral artery territory 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 Penicillin anaphylaxis or some other drugs allergy Autoimmune disease Inaccessibility for follow up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous stem cell transplantation<br>Intravenous transplantation of autologous bone marrow mesenchymal stem cell plus conventional treatment include rehabilitation | Genetic: Intravenous stem cell transplantation<br>* Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation<br>|
| No Intervention: Conventional treatment<br>Control group receive conventional stroke treatment that include rehabilitation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Fugl-Meyer Scale at 12 months |  | 1,3,6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in NIH Stroke Scale at 12 months |  | 1,3,6 and 12 months | 
| Change from baseline in Barthel Index at 12 months |  | 1,3,6 and 12 months | 
| Change from baseline in SSS at 12 months |  | 1,3,6 and 12 months | 
| Change from baseline in mRS at 12 months |  | 1,3,6 and 12 months | 
| Improvement of vision measured by brain visual examination |  | 1,6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Bone Marrow Mesenchymal Stem Cell, Transplantation