Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-28 @ 9:09 AM
Study NCT ID:
NCT01548261
Status:
UNKNOWN
Last Update Posted:
2012-03-08
First Post:
2012-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Donating Oral Mucosal Cells for the Study of ex Vivo Culture of Cells Sheets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Donating oral mucosal cells for the study of ex vivo culture of cells sheets.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-07', 'studyFirstSubmitDate': '2012-03-05', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obtain the oral mucosal tissue from healthy donors'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Cultivated oral mucosal epithelial sheets on amniotic membrane have been reported to have good clinical results in treating patients with ocular surface disorders in both human and animal studies. However, such technique has not been well established in this hospital. The main purpose of this study is to obtain the discarded oral mucosal tissue from healthy donors who volunteer to donate their oral mucosa from buccal area. The obtained oral mucosal tissue will be cultured under different types (co-culture with or without 3T3 cells)。Inverted light microscopy, electron microscopy and immunostaining with K3/K12, K14, Ki67, P63, connexin 43, and involucrin will be preformed to test the effects of foreskin cell line co-culture system on cell condition. The investigators plan to start the study from Jan. 1st, 2011 to Dec. 31th, 2015. Thirty patients will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Health people.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The age 20 to 55 year-old healthy contributor.\n* does not have disease of the oral cavity.\n\nExclusion Criteria:\n\n* In the past had the oral mucosa disease, wound cicatrization bad, or hemoglutination condition not good medical history. Sickness must stop using above any anti-hemoglutination medicine one week.'}, 'identificationModule': {'nctId': 'NCT01548261', 'briefTitle': 'Donating Oral Mucosal Cells for the Study of ex Vivo Culture of Cells Sheets', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'orgStudyIdInfo': {'id': '201110051RB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health people.', 'interventionNames': ['Procedure: Donating oral mucosal cells']}], 'interventions': [{'name': 'Donating oral mucosal cells', 'type': 'PROCEDURE', 'description': 'Donating oral mucosal cells', 'armGroupLabels': ['Health people.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wei Li Chen, MD, PhD', 'role': 'CONTACT', 'email': 'chenweili@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '65206'}], 'facility': 'National Taiwan University Hospital, department of Ophthalmology', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Wei Li Chen, MD, PhD', 'role': 'CONTACT', 'email': 'chenweili@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '65206'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology.', 'investigatorFullName': 'National Taiwan University Hospital', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}