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Implantation of Olfactory Ensheathing Cells (OECs) (OECs)

Primary Purpose

Infarction, Middle Cerebral Artery, Ischemic Stroke,, Stroke With Hemiparesis,

Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Olfactory ensheathing cells
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infarction, Middle Cerebral Artery focused on measuring Stroke,, Stem Cell,, Olfactory Ensheathing Cells,, Intracerebral Implantation of Olfactory Ensheathing Cells.

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China Medical University Hospital, Center of NeuropsychiatryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OECs, Medicine, Rehabilitation

Arm Description

Stroke patients are received intracerebral implantation of Olfactory ensheathing cells(OECs), Antiplatelet Medication, and Rehabilitation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 31, 2011
Last Updated
September 29, 2011
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01327768
Brief Title
Implantation of Olfactory Ensheathing Cells (OECs)
Acronym
OECs
Official Title
Evaluation of Safety, Feasibility and Treatment Potential for Old Stroke Patients Using Intracerebral Implantation of Olfactory Ensheathing Cells
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infarction, Middle Cerebral Artery, Ischemic Stroke,, Stroke With Hemiparesis,, Thromboembolic Stroke.
Keywords
Stroke,, Stem Cell,, Olfactory Ensheathing Cells,, Intracerebral Implantation of Olfactory Ensheathing Cells.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OECs, Medicine, Rehabilitation
Arm Type
Experimental
Arm Description
Stroke patients are received intracerebral implantation of Olfactory ensheathing cells(OECs), Antiplatelet Medication, and Rehabilitation.
Intervention Type
Procedure
Intervention Name(s)
Olfactory ensheathing cells
Other Intervention Name(s)
Stroke,, Stem Cells,, Olfactory Ensheathing Cells,, Early Phase Clinical Trial.
Intervention Description
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.
Primary Outcome Measure Information:
Title
NIH-Stroke Scale
Description
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.
Time Frame
within 1 year after surgery
Secondary Outcome Measure Information:
Title
MRI(DTI)
Description
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.
Time Frame
within 1 year after surgery
Title
TMS(MEP)
Description
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.
Time Frame
within 1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiao-Jung Wang, M.S.
Phone
886-4-22052121
Ext
7812
Email
city6364@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woei-Cherng Shyu, M.D., Ph.D
Organizational Affiliation
shyu9423@gmail.com
Official's Role
Study Chair
Facility Information:
Facility Name
China Medical University Hospital, Center of Neuropsychiatry
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiao-Jung Wang, M.S.
Phone
886-4-22052121
Ext
7812
Email
city6364@yahoo.com
First Name & Middle Initial & Last Name & Degree
Woei-Cherng Shyu, M.D., Ph.D

12. IPD Sharing Statement

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Implantation of Olfactory Ensheathing Cells (OECs)

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