Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-31 @ 2:11 PM
Study NCT ID:
NCT01613612
Status:
UNKNOWN
Last Update Posted:
2012-08-14
First Post:
2011-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implantation of Bone Marrow Cells to Treat Avascular Necrosis of Femoral Head (ANFH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005271', 'term': 'Femur Head Necrosis'}], 'ancestors': [{'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-12', 'studyFirstSubmitDate': '2011-12-13', 'studyFirstSubmitQcDate': '2012-06-05', 'lastUpdatePostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of Visual Analogue Scale', 'timeFrame': 'before invention and 24 months after invention', 'description': 'Change from baseline in 24 months'}, {'measure': 'change of lequensne algofunctional index', 'timeFrame': 'before invention and 24 months after invention', 'description': 'change from baseline in 24 months'}, {'measure': 'change of WOMAC index', 'timeFrame': 'before invention and 24 months after invention', 'description': 'change from baseline in 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Avascular Necrosis of Femur Head']}, 'referencesModule': {'references': [{'pmid': '32678055', 'type': 'DERIVED', 'citation': 'Li M, Ma Y, Fu G, Zhang R, Li Q, Deng Z, Zheng M, Zheng Q. 10-year follow-up results of the prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of the femoral head. Stem Cell Res Ther. 2020 Jul 16;11(1):287. doi: 10.1186/s13287-020-01810-8.'}, {'pmid': '25315149', 'type': 'DERIVED', 'citation': 'Ma Y, Wang T, Liao J, Gu H, Lin X, Jiang Q, Bulsara MK, Zheng M, Zheng Q. Efficacy of autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of femoral head: a prospective, double-blinded, randomized, controlled study. Stem Cell Res Ther. 2014 Oct 14;5(5):115. doi: 10.1186/scrt505.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of autologous enriched bone marrow cell implantation combined with core decompression to single core decompression for the treatment of avascular necrosis of femoral head.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* femoral head necrosis patients\n* stage I/II/III (Ficat)\n* age from 18 to 55 years\n* stop steroid treatment for minimal 6 months\n\nExclusion Criteria:\n\n* age younger than 18 or older than 55\n* any hemopathy\n* tumor\n* femoral head/neck fracture'}, 'identificationModule': {'nctId': 'NCT01613612', 'briefTitle': 'Implantation of Bone Marrow Cells to Treat Avascular Necrosis of Femoral Head (ANFH)', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Control Study of Implantation of Enriched Bone Marrow Cells for the Treatment of Avascular Necrosis of Femoral Head', 'orgStudyIdInfo': {'id': 'GGH_201112_Ortho_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'control group:core decompression', 'description': 'single core decompression', 'interventionNames': ['Procedure: core decompression']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group: BMCs+core decompression', 'description': 'Enriched bone marrow cells combined with core decompression', 'interventionNames': ['Procedure: Enriched BMCs implantation combined with core decompression']}], 'interventions': [{'name': 'core decompression', 'type': 'PROCEDURE', 'description': 'minimal surgical invention to drill a core to the femoral head to release pressure', 'armGroupLabels': ['control group:core decompression']}, {'name': 'Enriched BMCs implantation combined with core decompression', 'type': 'PROCEDURE', 'description': "Patients are subjected to bone marrow aspiration from the anterior iliac crest. Mononuclear cells are enriched from patients' bone marrow by centrifuge, which are grafted with autologous cortical bone and implanted to the necrotic zone of the femoral head.", 'armGroupLabels': ['Treatment group: BMCs+core decompression']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Orthopaedic Surgery', 'investigatorFullName': 'Qiujiang Zheng', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}