Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT04434794
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2020-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Gingival Recession Using Mesenchymal Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-13', 'studyFirstSubmitDate': '2020-06-13', 'studyFirstSubmitQcDate': '2020-06-13', 'lastUpdatePostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients cured', 'timeFrame': '1 month', 'description': 'number of patients cured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival Recession'], 'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'Treatment of patients with gingival recession by injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel', 'detailedDescription': 'Treatment of patients with gingival recession by injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel (1×106cells/0.2 ml). The volume of the mixture is divided into 4 equal injections in the gingival region of one tooth (one place injection volume is 0.05 ml of mixture).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-gingival recession\n\nExclusion Criteria:\n\n* pregnancy\n* breast-feeding\n* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis\n* mental disorders'}, 'identificationModule': {'nctId': 'NCT04434794', 'briefTitle': 'Treatment of Gingival Recession Using Mesenchymal Stem Cells', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus'}, 'officialTitle': 'Treatment of Gingival Recession Using Autologous Adipose-derived Mesenchymal Stem Cells', 'orgStudyIdInfo': {'id': 'IBCE_MSC(GR2)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mesenchymal stem cells', 'description': 'standard treatment according to clinical protocols plus mesenchymal stem cells', 'interventionNames': ['Biological: mesenchymal stem cells', 'Other: standard treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'standard treatment according to clinical protocols', 'interventionNames': ['Other: standard treatment']}], 'interventions': [{'name': 'mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'autologous mesenchymal stem cells', 'armGroupLabels': ['mesenchymal stem cells']}, {'name': 'standard treatment', 'type': 'OTHER', 'description': 'standard treatment according to clinical protocols', 'armGroupLabels': ['control', 'mesenchymal stem cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220072', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}], 'overallOfficials': [{'name': 'Igor D Volotovski, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the Lab of Institute of Biophysics and Cell Engineering'}, {'name': 'Sergey Rubnikovich, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the Department of Prosthodontics of BMAPE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Belarusian Medical Academy of Post-Graduate Education', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}