Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-28 @ 6:16 PM
Study NCT ID:
NCT05535803
Status:
UNKNOWN
Last Update Posted:
2022-09-10
First Post:
2022-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014135', 'term': 'Tracheal Stenosis'}, {'id': 'D007829', 'term': 'Laryngostenosis'}], 'ancestors': [{'id': 'D014133', 'term': 'Tracheal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D015619', 'term': 'Respiratory System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-09', 'studyFirstSubmitDate': '2022-08-26', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of patients who didn't require the repeated surgical interventions", 'timeFrame': '1 year', 'description': "Relative number of patients who didn't require the repeated surgical interventions after MSC therapy"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mesenchymal stem cells', 'Tracheal/Laryngeal Stenosis'], 'conditions': ['Tracheal Stenosis', 'Laryngeal Stenosis']}, 'descriptionModule': {'briefSummary': 'The trial evaluates the safety and efficacy of the olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis', 'detailedDescription': 'Trial evaluating the safety and efficacy of olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis with/without cartilage defects\n\nMesenchymal stem cells are obtained from tissue biopsy of olfactory mucosa using explant method. Biomass of autologous mesenchymal stem cells in 10% human albumin solution is injected submucosally around and over the tissue after removal of a granuloma tissue during surgical intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-confirmed diagnosis of chronic laryngeal or tracheal stenosis;\n\nExclusion Criteria:\n\n* refuse of patient to participate in the trial;\n* acute infectious diseases;\n* chronic mental disorders with severe manifestations;\n* pregnancy/lactation;\n* intercurrent severe chronic diseases;\n* HIV, Hepatites B/C;\n* active tuberculosis;\n* alcohol use disorder/drug addiction;\n* cachexia of any origin;\n* malignant neoplasms.'}, 'identificationModule': {'nctId': 'NCT05535803', 'briefTitle': 'Treatment of Laryngotracheal Stenosis 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 Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells', 'orgStudyIdInfo': {'id': 'IBCE_MSCStenosis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells', 'description': 'Patients with tracheal/laryngeal stenosis receiving standard surgical treatment and mesenchymal stem cells', 'interventionNames': ['Biological: Olfactory mucosa-derived mesenchymal stem cells', 'Other: Patients treated according to current clinical protocols']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with tracheal/laryngeal stenosis receiving standard treatment', 'description': 'Patients with tracheal/laryngeal stenosis receiving standard surgical treatment', 'interventionNames': ['Other: Patients treated according to current clinical protocols']}], 'interventions': [{'name': 'Olfactory mucosa-derived mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'Autologous olfactory mucosa-derived mesenchymal stem cells', 'armGroupLabels': ['Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells']}, {'name': 'Patients treated according to current clinical protocols', 'type': 'OTHER', 'description': 'Patients treated according to current clinical protocols', 'armGroupLabels': ['Patients with tracheal/laryngeal stenosis receiving standard treatment', 'Patients with tracheal/laryngeal stenosis receiving standard treatment and 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': 'Andrei Hancharou, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute for biophysics and cellular engineering NAS of Belarus'}, {'name': 'Elvira Strinkevich, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Republican Center for Research and Practice in Otolaryngology'}, {'name': 'Valery Chekan, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Republican Center for Research and Practice in Otolaryngology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The Republican Center for Research and Practice in Otolaryngology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}