Autologous Bone Marrow Stromal Cell and Endothelial Progenitor 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 feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke.

Detailed Description
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This study is a multi-center, single-blind, randomized, parallel controlled trail. Patients with acute cerebral infarcts within the middle cerebral arterial territory and with severe neurological deficits will be enrolled and randomly allocated into 3 groups: autologous BMSCs transplantation group, autologous EPCs transplantation group and Placebo control group. Randomization codes were established by the study statistician and were revealed only to the stem cell laboratory technician responsible for separating the cells into aliquots or preparing the placebo material. All patients will undergo a Bone Marrow aspiration procedure at 7 days after symptom onset. BMSCs and EPCs will be expanded ex vivo and then intravenously infused into own body, respectively. The control group will not receive cell therapy. Observe will followed for up to 1 year after the onset. Neurological score, neuroimaging, mortality of any cause, side effects, and new-onset comorbidities will be monitored and compared between each groups.

Official Title
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Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial

Conditions
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Stroke, Infarction, Middle Cerebral Artery

Intervention / Treatment
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* Genetic: Autologous BMSCs transplantation
* Genetic: Autologous EPCs transplantation
* Genetic: IV infusion of placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 80 years, within 7 days of the onset of symptoms Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI) The National Institutes of Health Stroke Scale (NIHSS) ≥ 7 at day 7 after the onset Signed informed consent Exclusion Criteria: Lacunar syndrome Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor) Hematological causes of stroke Severe respiratory, hepatic, or renal disorders Presence of severe febrile illness or viral diseases Malignant diseases Presence of autoimmune diseases Positive response of penicillin skin test, or multiple drug allergies Breast-feeding or pregnant women

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 |
| --- | --- |
| Experimental: BMSCs group<br> | Genetic: Autologous BMSCs transplantation<br>* The first transplantation: 2.5 million cells per kg autologous BMSCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration. The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting.<br>* Other names: Autologous Mesenchymal stem cells transplantation;|
| Experimental: EPCs group<br> | Genetic: Autologous EPCs transplantation<br>* The first transplantation: 2.5 million cells per kg autologous EPCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration. The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting.<br>* Other names: Autologous endothelial progenitor cells transplantation;|
| Placebo Comparator: Control group<br> | Genetic: IV infusion of placebo<br>* IV infusion of saline plus 5% autologous serum.<br>* Other names: Placebo control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events after infusion of BMSCs or EPCs. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI). |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central Nervous System Diseases, Stroke, Infarction, Middle Cerebral Artery, Cerebral Infarction, Cerebrovascular Accident, Stem Cell Transplantation, Mesenchymal Stem Cell Transplantation, Bone marrow stromal cells, Mesenchymal Stem Cells, Endothelial progenitor cells, Adult Stem Cells, Cell Therapy