Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00958802
Status:
COMPLETED
Last Update Posted:
2010-11-19
First Post:
2009-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065817', 'term': 'Congenital Microtia'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-18', 'studyFirstSubmitDate': '2009-08-12', 'studyFirstSubmitQcDate': '2009-08-12', 'lastUpdatePostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The aim of this study was to compare the histological and biochemical character of microtia chondrocytes treated with and without PRP.', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tissue engineering'], 'conditions': ['Microtia']}, 'descriptionModule': {'briefSummary': 'Platelet-rich plasma (PRP) has mixed growth factors such as TGF-ß1 and TGF-ß2, vascular epithelial growth factor (VEGF), platelet-derived growth factor (PDGF), and insulin-like growth factor (IGF). These growth factors appear to play an important role in wound healing and are assumed as promoters of tissue regeneration. Moreover, PRP was used as injectable scaffold seeded with chondrocytes to regenerate cartilage. In their previous study, the investigators concluded that growth factors in PRP can effectively react as a growth factor cocktail to induce human nucleus pulposus proliferation and differentiation, and also promote tissue-engineered nucleus pulposus formation. The investigators also have a hypothesis that PRP can promote tissue-engineered microtia auricular cartilage formation. TGF- ß1 exists in the highest concentration and is more important among all of the growth factors released from PRP. So TGF- ß1 can be used as the core ingredient and the indicator for applying PRP in these studies. The aim of this study was to compare the histological and biochemical character of microtia chondrocytes treated with and without PRP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* microtia patient\n\nExclusion Criteria:\n\n* non microtia patient'}, 'identificationModule': {'nctId': 'NCT00958802', 'briefTitle': 'Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies', 'orgStudyIdInfo': {'id': '98-WF-PHD-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm A', 'description': 'Chondrocyte culture with FBS medium', 'interventionNames': ['Other: Chondrocyte culture with FBS medium']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Chondrocyte culture with PRP', 'interventionNames': ['Other: Platelet-rich plasma (PRP)']}], 'interventions': [{'name': 'Platelet-rich plasma (PRP)', 'type': 'OTHER', 'description': 'PRP was extracted from total blood and TGF-b1 was used as indicator', 'armGroupLabels': ['Arm B']}, {'name': 'Chondrocyte culture with FBS medium', 'type': 'OTHER', 'description': 'Microtia chondrocyte culture with FBS medium only', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University, Wan Fang Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chia-Che Wu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chia-Che Wu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Chia-Che Wu, MD', 'oldOrganization': 'Taipei medical university- Wan Fang Hospital'}}}}