Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-26 @ 10:50 AM
Study NCT ID:
NCT01581892
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2012-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Adult Bone Marrow Mononuclear Cells in Patients With Long Bone Nonunion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}, {'id': 'C045071', 'term': 'leukocyte procoagulant activity'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2012-04-09', 'studyFirstSubmitQcDate': '2012-04-19', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of adverse effects during timeframe as infections or complications related with the intervention', 'timeFrame': 'Six months', 'description': 'The proposed trial will involve the recruitment of a total of 30 patients. The cells will be collected via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, wich will be resuspended in heparinized isotonic saline and used in order to infuse into the area surgically treated. The surgical intervention means the introduction of a sheet with nails according with the usually employed technique.'}], 'secondaryOutcomes': [{'measure': 'Improvement and union of the bone', 'timeFrame': 'One year', 'description': 'The improvement of the bone nonunion will be assessed by X-ray and NMR'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bone nonunion', 'bone marrow', 'mononuclear', 'fracture'], 'conditions': ['Long Bone Nonunion']}, 'referencesModule': {'references': [{'pmid': '23415918', 'type': 'BACKGROUND', 'citation': 'Fernandez-Bances I, Perez-Basterrechea M, Perez-Lopez S, Nunez Batalla D, Fernandez Rodriguez MA, Alvarez-Viejo M, Ferrero-Gutierrez A, Menendez-Menendez Y, Garcia-Gala JM, Escudero D, Paz Aparicio J, Carnero Lopez S, Lopez Fernandez P, Gonzalez Suarez D, Otero Hernandez J. Repair of long-bone pseudoarthrosis with autologous bone marrow mononuclear cells combined with allogenic bone graft. Cytotherapy. 2013 May;15(5):571-7. doi: 10.1016/j.jcyt.2013.01.004. Epub 2013 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the safety and feasibility of autologous mononuclear stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.', 'detailedDescription': 'In this study the investigators examine the improvement of conventional surgical treatment of long bone nonunion with the administration of bone marrow stem cells in order to achieve a higher percentage of healing and tissue reparation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed long bone nonunion\n* age from 18 years old\n\nExclusion Criteria:\n\n* active infection\n* cancer patients\n* concomitant serious illness\n* pregnant women\n* evidences of mental illness\n* previous alcohol or drug dependences\n* previous malignant disease during last 5 years, except for basal carcinoma'}, 'identificationModule': {'nctId': 'NCT01581892', 'briefTitle': 'Use of Adult Bone Marrow Mononuclear Cells in Patients With Long Bone Nonunion', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Central de Asturias'}, 'officialTitle': 'Treatment of Long Bone Nonunion With Autologous Bone Marrow Stem Cells. Phase I/II Study', 'orgStudyIdInfo': {'id': 'HUCA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bone marrow stem cells', 'description': 'Bone marrow is obtained by posterosuperior iliac crest aspiration under topical anesthesia. Mononuclear cells were isolated by Ficoll density gradient and will be resuspended in heparinized isotonic saline for mixing with osteogenic matrix.', 'interventionNames': ['Procedure: Osteosynthesis']}], 'interventions': [{'name': 'Osteosynthesis', 'type': 'PROCEDURE', 'otherNames': ['bone nonunion', 'bone marrow', 'mononuclear', 'fracture'], 'description': 'To mix the cell suspension with osteogenic matrix and to use sheet and nails in order to consolidate the fracture', 'armGroupLabels': ['Bone marrow stem cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33006', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}], 'overallOfficials': [{'name': 'Jesus Otero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unidad de Coordinación de Trasplantes, Terapia Celular y Medicina Regenerativa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Central de Asturias', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}