Ignite Creation Date:
2024-05-05 @ 11:23 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01327768
Status:
UNKNOWN
Last Update Posted:
2011-10-03
First Post:
2011-01-31
Brief Title:
Implantation of Olfactory Ensheathing Cells OECs
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
Evaluation of Safety Feasibility and Treatment Potential for Old Stroke Patients Using Intracerebral Implantation of Olfactory Ensheathing Cells
Status:
UNKNOWN
Status Verified Date:
2011-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OECs
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 106 cells in saline into the peri-infarcted area of the brain
Detailed Description:
1Recruited 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 106 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 IndexBI and MMSE will be performed for each patient to evaluate the therapeutic effect as the primary end points 4 In addition MRIDTI TMSMEP will be also checked for each recruitment patient as the secondary end points
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None