Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT00813267
Status:
UNKNOWN
Last Update Posted:
2012-10-10
First Post:
2008-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007873', 'term': 'Legg-Calve-Perthes Disease'}], 'ancestors': [{'id': 'D005271', 'term': 'Femur Head Necrosis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-06', 'studyFirstSubmitDate': '2008-12-21', 'studyFirstSubmitQcDate': '2008-12-22', 'lastUpdatePostDateStruct': {'date': '2012-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The femoral head blood-supply artery angiographies and the areas of femoral head necrosis', 'timeFrame': '2'}], 'secondaryOutcomes': [{'measure': 'Coxa joint paining', 'timeFrame': '2'}, {'measure': 'Walking distance', 'timeFrame': '2'}, {'measure': 'Joint functions', 'timeFrame': '2'}, {'measure': 'Life', 'timeFrame': '2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mesenchymal Stem Cells', 'Osteonecrosis of the Femoral Head'], 'conditions': ['Osteochondritis of the Femoral Head']}, 'descriptionModule': {'briefSummary': 'Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. The investigators will infuse expanded autologous MSCs and BMMNCs into patients with osteonecrosis of the femoral head. The study purpose is to examine whether this treatment will result in improvement in osteonecrosis of the femoral head.', 'detailedDescription': 'Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. Patients in this study will receive infusion of expanded autologous MSC and BMMNCs. The puncture of femoral artery will be conducted with digital subtraction angiography(DSA), and the tubes will be inserted into medial femoral circumflex artery,lateral femoral circumflex artery and obturatou artey. The study will evaluate the safety and effectiveness of MSC infusion in patients with osteonecrosis of the femoral head. This study will last for 5 years. Patients will undergo infusions at Day 0. Afterward, patients will be evaluated for response, and undergo X-ray examination, CT and MR scanning at a 6-month interval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages: 12 to 60 years old.\n* Association Research Circulation Osseous(ARCO) Classification criteria for osteonecrosis of the femoral head: ARCO phase I and phase II.\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Previous history of malignancy\n* Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.\n* Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in the past 6 months.\n* Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.\n* Any illness that in the opinion of the investigator would jeopardize the ability of the Patient to tolerate this treatment.'}, 'identificationModule': {'nctId': 'NCT00813267', 'briefTitle': 'Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head', 'organization': {'class': 'OTHER', 'fullName': 'Fuzhou General Hospital'}, 'officialTitle': 'Mesenchymal Stem Cell Transplantation in the Treatment of Osteonecrosis of the Femoral Head', 'orgStudyIdInfo': {'id': 'fuzhough1221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stem cell', 'description': 'mesenchymal stem cell infusion and bone marrow mononuclear cell infusion', 'interventionNames': ['Biological: mesenchymal stem cell infusion', 'Biological: bone marrow mononuclear cell infusion']}], 'interventions': [{'name': 'mesenchymal stem cell infusion', 'type': 'BIOLOGICAL', 'otherNames': ['MSC infusion'], 'armGroupLabels': ['stem cell']}, {'name': 'bone marrow mononuclear cell infusion', 'type': 'BIOLOGICAL', 'otherNames': ['BMMNC infusion'], 'armGroupLabels': ['stem cell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350025', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fuzhou General Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'overallOfficials': [{'name': 'Jianming Tan, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fuzhou General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jianming Tan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Jianming Tan', 'investigatorAffiliation': 'Fuzhou General Hospital'}}}}