Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 12:14 PM
Study NCT ID:
NCT03194451
Status:
UNKNOWN
Last Update Posted:
2017-06-23
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dental Stem Cells and Bone Tissue Engineering (CELSORDINO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014095', 'term': 'Tooth, Impacted'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'teeth'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-07-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2019-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-22', 'studyFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone mineralization', 'timeFrame': 'Day 28 of cell culture', 'description': 'Measured parameter is equal or superior to reference value (commercial differentiation medium)'}], 'secondaryOutcomes': [{'measure': 'presence and quantification of pseudo-vascular structures', 'timeFrame': 'Day 28 of cell culture', 'description': 'Measured parameter is equal or superior to reference value (commercial differentiation medium)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone tissue engineering, dental stem cell differentiation'], 'conditions': ['Tooth, Impacted']}, 'descriptionModule': {'briefSummary': 'The main limitation in bone regeneration is the lack of vascularization of the newly shaped tissue. The main objective of this project is to check if the simultaneous differentiation of dental mesenchymal stem cells toward osteoblastic and endothelial lineage permits to obtain a new pre-vascularized tissue engineered bone construct.\n\nWe will then evaluate the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.', 'detailedDescription': 'This project aims to develop a new pre-vascularized tissue engineered bone construct, using human cells of a simple and non invasive tissue source: dental pulp.\n\nWe will isolate mesenchymal stem cells from dental tissue of wisdom teeth, extracted from patients aged between 13 and 17 years old.\n\nThe objectives are: (i) to assess in combination the endothelial differentiation and osteoblastic differentiation of dental pulp stem cells (immature third molar); (ii) to study the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.\n\nThe differentiation will be monitored by evaluation of biosynthesized matrix, bone mineralization (immunohistochimie, Westen Blot), histological response (Von Kossa, Alizarin Red) and presence and quantification of pseudo-vascular structures (angiogenesis assay), compared to reference value (commercial differentiation medium).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged between 13 and 17 years, who will be operated for wisdom tooth avulsion', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients aged between 13 and 17 years, who will come to Dental Service of University Regional Hospital Center of Nancy in order to have a tooth avulsion.\n* patient who has received a complete information about research organization and who is not opposed to the use of his own data.\n* patient who the representatives of parental authority have received a complete information about research organization and who are not opposed to the use of children's data.\n\nExclusion Criteria:\n\n* patients with local or general pathology"}, 'identificationModule': {'nctId': 'NCT03194451', 'acronym': 'CELSORDINO', 'briefTitle': 'Dental Stem Cells and Bone Tissue Engineering (CELSORDINO)', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Dental Stem Cells and Bone Tissue Engineering', 'orgStudyIdInfo': {'id': '2017-A00860-53/EUDRACT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'non-interventional study', 'type': 'OTHER', 'description': 'teeth collection'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vanessa MOBY, DD, PhD', 'role': 'CONTACT', 'email': 'vanessa.moby@univ-lorraine.fr', 'phone': '0383154256', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Vanessa MOBY, DD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMoPA, UMR-CNRS 7365 CNRS-UL, Medicine Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}