Implantation of Olfactory Ensheathing Cells (OECs) (OECs)
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|ClinicalTrials.gov Identifier: NCT01327768|
Recruitment Status : Unknown
Verified September 2011 by China Medical University Hospital.
Recruitment status was: Recruiting
First Posted : April 4, 2011
Last Update Posted : October 3, 2011
|Condition or disease||Intervention/treatment||Phase|
|Infarction, Middle Cerebral Artery Ischemic Stroke, Stroke With Hemiparesis, Thromboembolic Stroke.||Procedure: Olfactory ensheathing cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Evaluation of Safety, Feasibility and Treatment Potential for Old Stroke Patients Using Intracerebral Implantation of Olfactory Ensheathing Cells|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||May 2013|
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.
- NIH-Stroke Scale [ Time Frame: within 1 year after surgery ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327768
|Contact: Hsiao-Jung Wang, M.S.||886-4-22052121 ext firstname.lastname@example.org|
|China Medical University Hospital, Center of Neuropsychiatry||Recruiting|
|Taichung, Taiwan, 40447|
|Contact: Hsiao-Jung Wang, M.S. 886-4-22052121 ext 7812 email@example.com|
|Principal Investigator: Woei-Cherng Shyu, M.D., Ph.D|
|Study Chair:||Woei-Cherng Shyu, M.D., Ph.Dfirstname.lastname@example.org|