Implantation of Olfactory Ensheathing Cells (OECs)

Study Overview
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Brief Summary
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Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The Olfactory Ensheathing Cells (OECs) will be cultured and expanded under the rule of GTP. Then, quality control of OECs should be done by immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain.

Detailed Description
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(1)Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The OECs will be cultured and expanded under the rule of GTP. Then, quality control of OECs should be done by immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators will transplanted the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain. (2) Combination with traditional drug therapy (such as used the anti-thrombosis reagent or anti-platelet aggregation reagent). (3) NIH-stroke scale (NIHSS), European stroke scale (ESS), European stroke motor subscale (EMS), Barthel Index(BI) and MMSE will be performed for each patient to evaluate the therapeutic effect as the primary end points. (4) In addition, MRI(DTI) & TMS(MEP) will be also checked for each recruitment patient as the secondary end points.

Official Title
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Evaluation of Safety, Feasibility and Treatment Potential for Old Stroke Patients Using Intracerebral Implantation of Olfactory Ensheathing Cells

Conditions
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Infarction, Middle Cerebral Artery, Ischemic Stroke,, Stroke With Hemiparesis,, Thromboembolic Stroke.

Intervention / Treatment
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* Procedure: Olfactory ensheathing cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 35-70 year old Chronic Stroke Adult Patients, With Stroke History of More Than 6 Months, Less Than 60 Months, With Stable Hemiplegia Condition, NIHSS Score Is Between 5 15. Exclusion Criteria: Patients Aged Less Than 35 or More Than 70, Hemorrhage Stroke or MRI Show The Occlusion Is Not In The Middle Cerebral Artery Territory, NIHSS Is Not In The Range of 5 15, Pregnant Women, Impaired Liver Function, Abnormal Blood Coagulation, AIDS Carrier, Tumors, Other Special Conditions, etc.

Ages Eligible for Study
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Minimum Age: 35 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OECs, Medicine, Rehabilitation<br>Stroke patients are received intracerebral implantation of Olfactory ensheathing cells(OECs), Antiplatelet Medication, and Rehabilitation. | Procedure: Olfactory ensheathing cells<br>* Recruited patients should be received the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The OECs will be cultured and expanded under the rule of GTP. Finally, we will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain for old stroke ischemic patients.<br>* Other names: Early Phase Clinical Trial.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH-Stroke Scale | National Institute of Health-Stroke Scale will be performed to evaluate including muscle power of hemiparetic limbs, sensory function and flurency of speech of each patient to document the therapeutic effect. | within 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI(DTI) | Magnetic Resonance Image (Diffusion Tensor Image) will be performed to evaluate the increase of the number of fiber tracts (pyramidal tract) in the stroke brain of each patient to document the therapeutic effect. | within 1 year after surgery | 
| TMS(MEP) | Trans-cranial Magnetic Stimulation (Motor Evoked Potential) will be performed to evaluate the electrophysiological response of stroke brain of each patient to document the therapeutic effect. | within 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke,, Stem Cell,, Olfactory Ensheathing Cells,, Intracerebral Implantation of Olfactory Ensheathing Cells.