Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-06 @ 2:09 AM
Study NCT ID:
NCT02375568
Status:
UNKNOWN
Last Update Posted:
2015-03-02
First Post:
2015-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Large-scale Expansion and Characterization of Mesenchymal Stem Cells for Clinical Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-24', 'studyFirstSubmitDate': '2015-02-10', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cell viability ratio of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage', 'timeFrame': '6 months'}, {'measure': 'Doubling time of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage', 'timeFrame': '6 months'}, {'measure': 'Percentage expression of cluster differentiation 90,105, 34, 45 surface markers of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Alcian blue staining of synovial membrane MSC and infrapatellar fat pad MSC', 'timeFrame': '6 months'}, {'measure': 'Tyep II collagen and aggrecan gene expression of synovial membrane MSC and infrapatellar fat pad MSC', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mesenchymal stem cells'], 'conditions': ['Knee Injuries']}, 'descriptionModule': {'briefSummary': 'According to many recent research, mesenchymal stem cells (MSC) isolated from synovial membrane and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency and ability to undergo chondrogenesis.\n\nBased on this concept, the investigators plan to get two removed tissues (synovial membrane and infrapatellar fat pad) from patients who have an operation of total knee replacement. The investigators are going to isolate and expand MSC from these two tissues respectively, and then compare the chondrogenesis ability for clinical application. In the other hand, the investigators plan to build techniques and procedures which comply with "Good Tissue Practices (GTP)"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who have an total knee replacement surgery', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatient who have an total knee replacement surgery\n\nExclusion Criteria:\n\nPatient who don't sign the agreement"}, 'identificationModule': {'nctId': 'NCT02375568', 'briefTitle': 'Large-scale Expansion and Characterization of Mesenchymal Stem Cells for Clinical Application', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Large-scale ex Vivo Expansion and Characterization of Synovial Membrane Mesenchymal Stem Cells (SM-MSC) and Infrapatellar Fat Pad Mesenchymal Stem Cells (IF-MSC) for Clinical Application', 'orgStudyIdInfo': {'id': '201405EMO'}}, 'armsInterventionsModule': {'armGroups': [{'label': '103024-F', 'description': 'For patients who have an operation of total knee replacement, two removed tissues (synovial membrane and infrapatellar fat pad) will be collected for mesenchymal stem cell isolation.', 'interventionNames': ['Other: 103024-F']}], 'interventions': [{'name': '103024-F', 'type': 'OTHER', 'description': 'mesenchymal stem cell isolation', 'armGroupLabels': ['103024-F']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220', 'city': 'Pan-Ciao', 'state': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chih-Hung Chang, Ph. D', 'role': 'CONTACT', 'email': 'orthocch@mail.femh.org.tw', 'phone': '886-2-89667000', 'phoneExt': '2888'}], 'facility': 'Far Eastern Memorial Hospital'}], 'centralContacts': [{'name': 'Chih-Hung Chang, MD, Ph.D', 'role': 'CONTACT', 'email': 'orthocch@mail.femh.org.tw', 'phone': '886-2-89667000', 'phoneExt': '2888'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chin-Hung Chang', 'class': 'OTHER'}, 'collaborators': [{'name': 'EMO Biomedicine Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD. PhD.', 'investigatorFullName': 'Chin-Hung Chang', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}