Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT01513694
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2012-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535531', 'term': 'Intervertebral disc disease'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2012-01-16', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mesenchymal Stem Cells', 'Stem Cells', 'Intervertebral disc disease'], 'conditions': ['Intervertebral Disc Disease']}, 'referencesModule': {'references': [{'pmid': '37038216', 'type': 'DERIVED', 'citation': 'Gomez-Ruiz V, Blanco JF, Villaron EM, Fidalgo H, Lopez-Parra M, Sanchez-Guijo F. Autologous mesenchymal stem cell transplantation for spinal fusion: 10 years follow-up of a phase I/II clinical trial. Stem Cell Res Ther. 2023 Apr 11;14(1):78. doi: 10.1186/s13287-023-03298-4.'}, {'pmid': '30795797', 'type': 'DERIVED', 'citation': 'Blanco JF, Villaron EM, Pescador D, da Casa C, Gomez V, Redondo AM, Lopez-Villar O, Lopez-Parra M, Muntion S, Sanchez-Guijo F. Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up. Stem Cell Res Ther. 2019 Feb 22;10(1):63. doi: 10.1186/s13287-019-1166-4.'}], '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 trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical\n\n* Box symptomatic (back pain and / or root) of lumbar degenerative disc disease monosegmental.\n* Discopathy refractory to conservative treatment (drugs, physical therapy.)\n* Evolution greater than or equal to 6 months. Radiological\n* Discopathy radiation. Disc space narrowing, osteophytes, abnormal mobility, etc\n* NMR: grades IV and V of Pfirman.\n\nExclusion Criteria:\n\n* Rejection of surgical treatment.\n* Systemic inflammatory disease (spondylitis, rheumatoid arthritis etc), tumor or infection.\n* Immunosuppressive treatment.\n* Congenital or acquired anatomical abnormality that prevents the surgical procedure.\n* Neuropsychiatric pathology, drug addiction, psychosis, severe personality disorder.\n* High surgical risk (ASA\\> IV), or contraindication to anesthesia.'}, 'identificationModule': {'nctId': 'NCT01513694', 'briefTitle': 'Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Red de Terapia Celular'}, 'officialTitle': 'Clinical Trial Phase I / II Prospective, Open, Non-randomized for Treatment of Lumbar Intervertebral Degenerative Disc Disease With Posterolateral Instrumented and Autologous Mesenchymal Stem Cells.', 'orgStudyIdInfo': {'id': 'CSM/Fusión/2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSC seeded onto a phosphate ceramic', 'description': 'Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.', 'interventionNames': ['Procedure: Instrumented posterolateral arthrodesis']}], 'interventions': [{'name': 'Instrumented posterolateral arthrodesis', 'type': 'PROCEDURE', 'description': 'Cell suspension of 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 used a minimum dose of 0.5 x106 CSM / kg and a maximum of 1, 5x106 CSM / kg of patient weight.\n\nDosage Form: Suspension cell support hydroxyapatite and calcium phosphate Route of administration: placement in the fusion bed during surgery.', 'armGroupLabels': ['MSC seeded onto a phosphate ceramic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37007', 'city': 'Salamanca', 'state': 'Castille and León', 'country': 'Spain', 'facility': 'Trauma Service. Hospital Universitario de 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'}}}}