Implantation of Olfactory Ensheathing Cells (OECs)

Infarction, Middle Cerebral Artery Clinical Trial

— OECs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01327768
• Other study ID #: CN1U00-1
• Status: Recruiting
• Phase: Phase 1
• First received: January 31, 2011
• Last updated: September 29, 2011
• Start date: January 2011
• Est. completion date: May 2013

Study information

• Verified date: September 2011
• Source: China Medical University Hospital
• Contact: Hsiao-Jung Wang, M.S.
• Phone: 886-4-22052121
• Email: city6364[@]yahoo.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital, Center of Neuropsychiatry	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes