Implantation of Olfactory Ensheathing Cells (OECs)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01327768
First received: January 31, 2011
Last updated: September 29, 2011
Last verified: September 2011
  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

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:
  • Stroke,
  • Stem Cells,
  • Olfactory Ensheathing Cells,
  • Early Phase Clinical Trial.

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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327768

Contacts
Contact: Hsiao-Jung Wang, M.S. 886-4-22052121 ext 7812 city6364@yahoo.com

Locations
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         
Sponsors and Collaborators
China Medical University Hospital
Investigators
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:
Stroke
Cerebral Infarction
Paresis
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 April 17, 2014