Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT05305833
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2021-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-23', 'studyFirstSubmitDate': '2021-11-12', 'studyFirstSubmitQcDate': '2022-03-23', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Pain at 15th day', 'timeFrame': '15th day', 'description': 'using by Visual Analogue Scale (VAS); higher scores mean worse outcome'}, {'measure': 'Change from baseline maximum mouth opening at 15th day', 'timeFrame': '15th day', 'description': 'the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly'}, {'measure': 'Change from baseline maximum mouth opening at 1 month', 'timeFrame': '1. month', 'description': 'the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at first month; higher scores means a better outcome'}, {'measure': 'Change from baseline maximum mouth opening at 3 months', 'timeFrame': '3. month', 'description': 'the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at third month; higher scores means a better outcome'}, {'measure': 'Change from baseline maximum mouth opening at 6 months', 'timeFrame': '6. month', 'description': 'the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at 6th month,higher scores means a better outcome'}, {'measure': 'Change from baseline pain at 1 month', 'timeFrame': '1. month', 'description': 'using by Visual Analogue Scale (VAS)'}, {'measure': 'Change from baseline pain at 3 month', 'timeFrame': '3. month', 'description': 'using by Visual Analogue Scale (VAS)'}, {'measure': 'Change from baseline pain at 6 month', 'timeFrame': '6. month', 'description': 'using by Visual Analogue Scale (VAS) higher scores mean worse outcome'}], 'secondaryOutcomes': [{'measure': "Change from baseline 'comfort ' at 6th month", 'timeFrame': '6 months', 'description': 'using by Visual Analogue Scale (VAS); higher scores mean better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temporomandibular Joint Disorders', 'Temporomandibular Disorder', 'Temporomandibular Joint Osteoarthritis', 'Temporomandibular Joint Pain', 'Temporomandibular Joint Effusion']}, 'descriptionModule': {'briefSummary': 'It will be evaluate the safety of mesenchymal stem cells and adipose tissue derived stromal vascular fraction (SVF) in temporomandibular joint disease cases.', 'detailedDescription': 'umbilical cord derived mesenchymal stem cells produced under GMP facility in Erciyes University and SVF produced in operation theatre.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic temporomandibular arthritic disorder\n* History of pain and joint noises for at least 3 months\n* Must have more than VAS 5 TMJ pain\n* must have internal derangement of TMJ\n* Limited mouth opening\n* Magnetic resonance imaging evidence of effusion or degeneration\n* Already treated with conservative methods (occlusal splint,pharmacological and/or physio-kinesio therapy) without satisfactory benefit.\n\nExclusion Criteria:\n\n* Cancer patients\n* Immunosupressed patients\n* Previous TMJ traumas and fractures\n* Previous TMJ surgeries\n* TMJ ankylosis'}, 'identificationModule': {'nctId': 'NCT05305833', 'briefTitle': 'Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Stem Cells Transplantation for Temporomandibular Joint Disease: Phase I/II Study', 'orgStudyIdInfo': {'id': '2021/584'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'umbilical cord derived mesenchymal stem cells transplantation group', 'description': 'taking umbilical cord derived mesenchymal stem cells', 'interventionNames': ['Biological: Stem Cells']}, {'type': 'EXPERIMENTAL', 'label': 'stromal vascular fraction cells application group', 'description': 'taking stromal vascular fraction cells', 'interventionNames': ['Biological: Stem Cells']}], 'interventions': [{'name': 'Stem Cells', 'type': 'BIOLOGICAL', 'description': 'ATMP', 'armGroupLabels': ['stromal vascular fraction cells application group', 'umbilical cord derived mesenchymal stem cells transplantation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Genkok Center', 'role': 'CONTACT', 'phone': '00903522076666', 'phoneExt': '13600'}, {'name': 'ALPER KEMALOGLU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'IRFAN OZYAZGAN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'GOKCEN DINC, PHD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Erciyes University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'centralContacts': [{'name': 'Zeynep B Gonen, DDS,PHD', 'role': 'CONTACT', 'email': 'zburcin@gmail.com', 'phone': '00903522076666', 'phoneExt': '13602'}, {'name': 'Genkok center', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Zeynep B Gonen, DDS,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assoc.Prof'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zeynep Burcin GONEN', 'investigatorAffiliation': 'TC Erciyes University'}}}}