Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke

Study Overview
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Brief Summary
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Stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

Detailed Description
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For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by a life-long process of clinical support. However, even with rehabilitation therapy, 50% to 95% of stroke survivors remain impaired. There is thus a great need for new therapeutic developments for patients with disability after stroke, which is largely unexplored. Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem cells might be possible for dead or injured neural cells to be replaced after acute stroke. 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 stroke. The neurological outcome will be determined after transplantation.

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

Conditions
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Stroke

Intervention / Treatment
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* Genetic: intracerebral stem cell transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 40-70 ischemia stroke or intracerebral hemorrhage patient With stroke history of more than 3 months, less than 60 months With stable hemiplegia condition NIHSS (NIH stroke scale) score of 7 or more points Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar <7 mg, and normal urea/electrolytes for at least 48 hours.) Exclusion Criteria: Patients aged less than 40 or more than 70 Lacunar infarction History of neurological disease, head injury or psychiatric disorder with disablity Pregnant women Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition Inaccessibility for follow up Unwillingness to provide written informed consent

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intracerebral stem cell transplantation<br>Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation | Genetic: intracerebral stem cell transplantation<br>* Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient<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 NIH Stroke Scale at 12 months |  | 1, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of infarct size measured by brain MRI |  | 1,6 and 12 months after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic, Ischemic Stroke, Intracerebral Hemorrhage, Bone Marrow Mesenchymal Stem Cell