Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 3:13 PM
Study NCT ID:
NCT01788059
Status:
COMPLETED
Last Update Posted:
2013-12-30
First Post:
2013-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-03-27', 'releaseDate': '2014-02-13'}, {'resetDate': '2014-06-14', 'releaseDate': '2014-05-17'}, {'resetDate': '2018-02-16', 'releaseDate': '2017-08-02'}], 'estimatedResultsFirstSubmitDate': '2014-02-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005599', 'term': 'Fractures, Ununited'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-26', 'studyFirstSubmitDate': '2013-01-17', 'studyFirstSubmitQcDate': '2013-02-07', 'lastUpdatePostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical and radiological union at 1 month to 6 months', 'timeFrame': '6 months', 'description': 'patients receiving Mesenchymal Stem Cells that develop a partial or complete callus at 1, 2, 3, 4 ,5 and 6 months evaluate with standard X-rays'}], 'secondaryOutcomes': [{'measure': '•Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects.', 'timeFrame': '12 months'}, {'measure': 'Incidence of adverse events in patients (e.g infection , malignancy , ...) Adverse events will be continuously monitored', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nonunion', 'mesenchymal stem cell', 'long bone'], 'conditions': ['Nonunion Fracture']}, 'descriptionModule': {'briefSummary': 'Because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union on the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. Therefore the investigators decide to inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure to non union site in patient that are resistant to other treatment. Then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment.clinical union consider to relief pain in non union site and be stable in examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every patient with non union in the site of long bone fracture\n* Age more than 18 and under 60 years old\n* Fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction.\n* No infection in site of surgery\n* Be able and willing to participate in the study\n* Written informed consent\n\nExclusion Criteria:\n\n* Evidence of malignancy\n* Pregnancy or breastfeeding\n* Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing'}, 'identificationModule': {'nctId': 'NCT01788059', 'briefTitle': 'The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Emdadi Kamyab Hospital'}, 'officialTitle': 'The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital', 'orgStudyIdInfo': {'id': '900939'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mesenchymal stem cell', 'description': 'stem cells drived from iliac bone marrow with centrifuge and ficoll method then inject to non union site 2-3 ml with approximately 40 X 10E6 Mesenchymal Stem Cells (MSC) will be injected in the nonunion site of the bone fracture under fluoroscopic gide and general or spinal anesthesia as deemed appropriate by the anesthetist.', 'interventionNames': ['Other: injection the mesenchymal stem cell in non union site']}], 'interventions': [{'name': 'injection the mesenchymal stem cell in non union site', 'type': 'OTHER', 'armGroupLabels': ['mesenchymal stem cell']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mashhad', 'state': 'Khorasan', 'country': 'Iran', 'facility': 'Emdai Kamyab Hospital', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}], 'overallOfficials': [{'name': 'mohammad taghi peivandi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emdadi Kamyab Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emdadi Kamyab Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'mohammad taghi peivandi', 'investigatorAffiliation': 'Emdadi Kamyab Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-02-13', 'type': 'RELEASE'}, {'date': '2014-03-27', 'type': 'RESET'}, {'date': '2014-05-17', 'type': 'RELEASE'}, {'date': '2014-06-14', 'type': 'RESET'}, {'date': '2017-08-02', 'type': 'RELEASE'}, {'date': '2018-02-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'mohammad taghi peivandi, MD, Emdadi Kamyab Hospital'}}}}