Implantation of Olfactory Ensheathing Cells (OECs)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infarction, Middle Cerebral Artery Ischemic Stroke, Stroke With Hemiparesis, Thromboembolic Stroke. |
Procedure: Olfactory ensheathing cells |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Evaluation of Safety, Feasibility and Treatment Potential for Old Stroke Patients Using Intracerebral Implantation of Olfactory Ensheathing Cells |
- NIH-Stroke Scale [ Time Frame: within 1 year after surgery ] [ Designated as safety issue: Yes ]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.
- MRI(DTI) [ Time Frame: within 1 year after surgery ] [ Designated as safety issue: Yes ]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.
- TMS(MEP) [ Time Frame: within 1 year after surgery ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 6 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: OECs, Medicine, Rehabilitation
Stroke patients are received intracerebral implantation of Olfactory ensheathing cells(OECs), Antiplatelet Medication, and Rehabilitation.
|
Procedure: Olfactory ensheathing cells
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.
Other Names:
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Detailed Description:
(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.
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Hsiao-Jung Wang, M.S. | 886-4-22052121 ext 7812 | city6364@yahoo.com |
| Taiwan | |
| China Medical University Hospital, Center of Neuropsychiatry | Recruiting |
| Taichung, Taiwan, 40447 | |
| Contact: Hsiao-Jung Wang, M.S. 886-4-22052121 ext 7812 city6364@yahoo.com | |
| Principal Investigator: Woei-Cherng Shyu, M.D., Ph.D | |
| Study Chair: | Woei-Cherng Shyu, M.D., Ph.D | shyu9423@gmail.com |
More Information
No publications provided
| Responsible Party: | China Medical University Hospital |
| ClinicalTrials.gov Identifier: | NCT01327768 History of Changes |
| Other Study ID Numbers: | CN1U00-1 |
| Study First Received: | January 31, 2011 |
| Last Updated: | September 29, 2011 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by China Medical University Hospital:
|
Stroke, Stem Cell, Olfactory Ensheathing Cells, Intracerebral Implantation of Olfactory Ensheathing Cells. |
Additional relevant MeSH terms:
|
Paresis Infarction Stroke Cerebral Infarction Infarction, Middle Cerebral Artery Neurologic Manifestations Nervous System Diseases Signs and Symptoms Ischemia Pathologic Processes |
Necrosis Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Cerebral Arterial Diseases Intracranial Arterial Diseases |
ClinicalTrials.gov processed this record on June 18, 2013