Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT00557635
Status:
SUSPENDED
Last Update Posted:
2009-09-23
First Post:
2007-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'whyStopped': 'no recruited patients', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-22', 'studyFirstSubmitDate': '2007-11-12', 'studyFirstSubmitQcDate': '2007-11-12', 'lastUpdatePostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate osseous setting at 3-months follow-up and compare our results with past studies', 'timeFrame': 'at 3-months follow-up'}], 'secondaryOutcomes': [{'measure': 'Feasibility and tolerance of this therapeutic strategy', 'timeFrame': 'at 3-months follow-up'}]}, 'conditionsModule': {'keywords': ['pseudo-arthrosis, osseous matrix, cell therapy'], 'conditions': ['Tibia or Femur Pseudo-arthrosis']}, 'descriptionModule': {'briefSummary': "Sometime osseous reconstruction needs allogeneic bone, in this study we use Ostéopure™ from Ostéobanque d'Auvergne, which is a osseous matrix. However Ostéopure™ integration lasts a long time. To optimize this integration we purpose to associate mesenchymal progenitors cells from autologous bone marrow.", 'detailedDescription': 'All patients will be treated for tibia or femur pseudo-arthrosis. At the beginning of chirurgical intervention, autologous bone marrow will be sampling and will be concentrated during this one.\n\nMeanwhile osseous matrix (Ostéopure™ ) will be incubated in autologous blood serum and finally implanted in the fracture site. And after (at the end of chirurgical intervention), concentrate autologous bone marrow will be injected in the same place.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* tibia or femur pseudo-arthrosis,\n* patient who needs bone graft\n\nExclusion Criteria:\n\n* \\- contra indications for chirurgical intervention or bone graft'}, 'identificationModule': {'nctId': 'NCT00557635', 'briefTitle': 'Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow', 'orgStudyIdInfo': {'id': 'CHU-0026'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Chirurgical procedure', 'type': 'PROCEDURE', 'description': 'Chirurgical procedure to treat pseudo-arthrosis, with of osseous matrix implantation and autologous bone marrow injection.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marc Berger, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Marc Berger', 'oldOrganization': 'CHU Clermont-Ferrand'}}}}