Implantation of Olfactory Ensheathing Cells (OECs)
OECs
Evaluation of Safety, Feasibility and Treatment Potential for Old Stroke Patients Using Intracerebral Implantation of Olfactory Ensheathing Cells
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 31, 2011
CompletedFirst Posted
Study publicly available on registry
April 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedOctober 3, 2011
September 1, 2011
2.3 years
January 31, 2011
September 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
MRI(DTI)
within 1 year after surgery
TMS(MEP)
within 1 year after surgery
Study Arms (1)
OECs, Medicine, Rehabilitation
EXPERIMENTALStroke patients are received intracerebral implantation of Olfactory ensheathing cells(OECs), Antiplatelet Medication, and Rehabilitation.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital, Center of Neuropsychiatry
Taichung, 40447, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Woei-Cherng Shyu, M.D., Ph.D
shyu9423@gmail.com
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2011
First Posted
April 4, 2011
Study Start
January 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
October 3, 2011
Record last verified: 2011-09