Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT04493918
Status:
UNKNOWN
Last Update Posted:
2020-08-03
First Post:
2020-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014399', 'term': 'Tuberculosis, Spinal'}], 'ancestors': [{'id': 'D014394', 'term': 'Tuberculosis, Osteoarticular'}, {'id': 'D000092225', 'term': 'Tuberculosis, Extrapulmonary'}, {'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants do not know which treatment they receives. Outcome assessor is a radiologist'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vertebral bony fusion', 'timeFrame': '1 Year', 'description': 'trabecular bone on xray and CT scan'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mycobacterium tuberculosis'], 'conditions': ['Spinal Tuberculosis', 'Mesenchymal Stem Cell']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of locally implantation of mesenchymal stem cell on vertebral bone defects due to infection of mycobacterium tuberculosis. there are controlled participants who receives placebo and patients who receives implantation of MSc', 'detailedDescription': 'Mesenchymal Stem Cell are implanted in Spinal Tuberculosis patient. MSC has inflammatory effect and the ability to form into new bone.\n\nIn Spinal Tuberculosis, the spread of bacteria is commonly hematogenous, where the focus of infection is at the anterior part of the vertebrae near the subchondral bone. The infection process continues, where the necrotic casseous fragments formed into local abcess that may spread to the sorrounding area.\n\nPatient with spinal tuberculosis who receives Anti TB Drug, is planned to undergo debridement, spinal stabilization. After thorough debridement, patient who fall into control group receives normal saline injection, patients who fall into treatment group will receive Mesenchymal Stem Cell.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '64 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinicoradiologically diagnoses Spinal Tuberculosis\n* receives Anti TB drugs\n* minimun destruction 1/3 vertebral body\n\nExclusion Criteria:\n\n* patient under 15 years old\n* reject to be included in the study'}, 'identificationModule': {'nctId': 'NCT04493918', 'briefTitle': 'Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)', 'orgStudyIdInfo': {'id': '18-04-0389'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSC Group', 'description': 'Mesenchymal Stem Cell + NaCl 0,9% 2ml', 'interventionNames': ['Combination Product: Mesenchymal Stem cell + Nacl 0.9%', 'Combination Product: NaCl 0.9%']}], 'interventions': [{'name': 'Mesenchymal Stem cell + Nacl 0.9%', 'type': 'COMBINATION_PRODUCT', 'description': 'Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml + MSC 30 million unit', 'armGroupLabels': ['MSC Group']}, {'name': 'NaCl 0.9%', 'type': 'COMBINATION_PRODUCT', 'description': 'Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml', 'armGroupLabels': ['MSC Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Ahmad Jabir Rahyussalim, MD,PhD,SpOT', 'role': 'CONTACT', 'email': 'rahyussalim71@ui.ac.id', 'phone': '+62811819466'}, {'name': 'Trie K Kurniawati, SSi', 'role': 'CONTACT', 'email': 'trie3k@ui.ac.id', 'phone': '+628121134311'}, {'name': 'Ahmad Jabir Rahyussalim, MD,PhD,SpOT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Ahmad Jabir Rahyussalim, PhD', 'role': 'CONTACT', 'email': 'rahyussalim71@ui.ac.id', 'phone': '+62811819466'}, {'name': 'Tri Kurniawati, Mrs', 'role': 'CONTACT', 'email': 'trie3k@ui.ac.id', 'phone': '+628121134311'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmad Jabir Rahyussalim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. dr. Rahyussalim SpOT(K)', 'investigatorFullName': 'Ahmad Jabir Rahyussalim', 'investigatorAffiliation': 'Indonesia University'}}}}