Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-29 @ 11:52 PM
Study NCT ID:
NCT01327768
Status:
UNKNOWN
Last Update Posted:
2011-10-03
First Post:
2011-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implantation of Olfactory Ensheathing Cells (OECs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020244', 'term': 'Infarction, Middle Cerebral Artery'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002539', 'term': 'Cerebral Arterial Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-09-29', 'studyFirstSubmitDate': '2011-01-31', 'studyFirstSubmitQcDate': '2011-04-01', 'lastUpdatePostDateStruct': {'date': '2011-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NIH-Stroke Scale', 'timeFrame': 'within 1 year after surgery', '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.'}], 'secondaryOutcomes': [{'measure': 'MRI(DTI)', 'timeFrame': 'within 1 year after surgery', '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.'}, {'measure': 'TMS(MEP)', 'timeFrame': 'within 1 year after surgery', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke,', 'Stem Cell,', 'Olfactory Ensheathing Cells,', 'Intracerebral Implantation of Olfactory Ensheathing Cells.'], 'conditions': ['Infarction, Middle Cerebral Artery', 'Ischemic Stroke,', 'Stroke With Hemiparesis,', 'Thromboembolic Stroke.']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '(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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 35-70 year old Chronic Stroke Adult Patients,\n* With Stroke History of More Than 6 Months, Less Than 60 Months,\n* With Stable Hemiplegia Condition,\n* NIHSS Score Is Between 5\\~15.\n\nExclusion Criteria:\n\n* Patients Aged Less Than 35 or More Than 70,\n* Hemorrhage Stroke or MRI Show The Occlusion Is Not In The Middle Cerebral Artery Territory,\n* NIHSS Is Not In The Range of 5\\~15,\n* Pregnant Women,\n* Impaired Liver Function, Abnormal Blood Coagulation, AIDS Carrier, Tumors, Other Special Conditions, etc.'}, 'identificationModule': {'nctId': 'NCT01327768', 'acronym': 'OECs', 'briefTitle': 'Implantation of Olfactory Ensheathing Cells (OECs)', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Evaluation of Safety, Feasibility and Treatment Potential for Old Stroke Patients Using Intracerebral Implantation of Olfactory Ensheathing Cells', 'orgStudyIdInfo': {'id': 'CN1U00-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OECs, Medicine, Rehabilitation', 'description': 'Stroke patients are received intracerebral implantation of Olfactory ensheathing cells(OECs), Antiplatelet Medication, and Rehabilitation.', 'interventionNames': ['Procedure: Olfactory ensheathing cells']}], 'interventions': [{'name': 'Olfactory ensheathing cells', 'type': 'PROCEDURE', 'otherNames': ['Stroke,', 'Stem Cells,', 'Olfactory Ensheathing Cells,', 'Early Phase Clinical Trial.'], '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.', 'armGroupLabels': ['OECs, Medicine, Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40447', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsiao-Jung Wang, M.S.', 'role': 'CONTACT', 'email': 'city6364@yahoo.com', 'phone': '886-4-22052121', 'phoneExt': '7812'}, {'name': 'Woei-Cherng Shyu, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'China Medical University Hospital, Center of Neuropsychiatry', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Hsiao-Jung Wang, M.S.', 'role': 'CONTACT', 'email': 'city6364@yahoo.com', 'phone': '886-4-22052121', 'phoneExt': '7812'}], 'overallOfficials': [{'name': 'Woei-Cherng Shyu, M.D., Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'shyu9423@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}