Clinical trial NCT01327768: Implantation of Olfactory Ensheathing Cells (OECs)
Official title: Evaluation of Safety, Feasibility and Treatment Potential for Old Stroke Patients Using Intracerebral Implantation of Olfactory Ensheathing Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Infarction, Middle Cerebral Artery
Ischemic Stroke,
Stroke With Hemiparesis,
Thromboembolic Stroke.
Keywords: Stroke,
Stem Cell,
Olfactory Ensheathing Cells,
Intracerebral Implantation of Olfactory Ensheathing Cells.
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-04-04
Enrollment: 6
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: (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 criteria: 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.

Primary outcomes:
measure: NIH-Stroke Scale
timeFrame: within 1 year after surgery
Secondary outcomes:
measure: MRI(DTI)
timeFrame: within 1 year after surgery
measure: TMS(MEP)
timeFrame: within 1 year after surgery
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital, Center of Neuropsychiatry
Study officials:
affiliation: shyu9423@gmail.com
name: Woei-Cherng Shyu, M.D., Ph.D
role: STUDY_CHAIR
References: