Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT01700920
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2012-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2012-10-02', 'studyFirstSubmitQcDate': '2012-10-02', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteonecrosis of the femoral head', 'Stem Cell', 'Mesenchymal Stem Cells', 'Femoral Head'], 'conditions': ['Osteonecrosis of the Femoral Head']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.red-tercel.com', 'label': 'Spanish cell therapy network (TerCel)'}, {'url': 'http://fundacion.usal.es', 'label': 'Salamanca University Foundation'}, {'url': 'http://www.isciii.es', 'label': 'Spanish Health Institute Carlos III'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral osteonecrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head\n* Stadiums \\<IIIC ARCO ranking\n\nExclusion Criteria:\n\n* Those on investigator judgment not in a good position to tolerate the procedure.\n* Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)\n* Serious illness uncontrolled\n* Pregnant women\n* Patients with HIV infection +\n* Acute infection (in the previous 15 days) or chronic (other than HIV)\n* Previous treatments of osteonecrosis\n* Active or previous neoplastic disease (last 5 years) except for patients undergoing allogeneic haematopoietic progenitors who are in complete remission after 2 years after transplantation.\n* Lack of informed consent or revocation thereof.'}, 'identificationModule': {'nctId': 'NCT01700920', 'acronym': 'CSM/ON/2011', 'briefTitle': 'PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells', 'organization': {'class': 'INDUSTRY', 'fullName': 'Red de Terapia Celular'}, 'officialTitle': 'PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells', 'orgStudyIdInfo': {'id': 'CSM/ON/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesenchymal Stem Cell', 'description': 'Cell suspension mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products.\n\nThey employ a minimum dose of 0.5 x 106 MSC / kg and a maximum of 1, 0x106 CSM / kg of patient weight.\n\nPharmaceutical form: Suspension cell Route of administration: local implant intraosseous injection with trocar in the femoral head.', 'interventionNames': ['Procedure: bone marrow aspirate']}], 'interventions': [{'name': 'bone marrow aspirate', 'type': 'PROCEDURE', 'armGroupLabels': ['Mesenchymal Stem Cell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37007', 'city': 'Salamanca', 'state': 'Castille and León', 'country': 'Spain', 'facility': 'University Hospital of Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Red de Terapia Celular', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán', 'class': 'OTHER'}, {'name': 'Spanish National Health System', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}