Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT01207193
Status:
COMPLETED
Last Update Posted:
2011-12-14
First Post:
2010-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001845', 'term': 'Bone Cysts'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D043182', 'term': 'Carboxylesterase'}, {'id': 'D017690', 'term': 'Cell Transplantation'}], 'ancestors': [{'id': 'D002265', 'term': 'Carboxylic Ester Hydrolases'}, {'id': 'D004950', 'term': 'Esterases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-13', 'studyFirstSubmitDate': '2010-09-21', 'studyFirstSubmitQcDate': '2010-09-21', 'lastUpdatePostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fulfill bone cyst defect', 'timeFrame': '6 months', 'description': 'Defect of bone due to cyst fulfill after cell transplantation.'}], 'secondaryOutcomes': [{'measure': 'effect of mesenchymal cell transplantation', 'timeFrame': '6 months', 'description': 'Evaluate effect of mesenchymal cell transplantation to fulfill the defect of bone cyst.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bone cyst bone defect mesenchymal cell'], 'conditions': ['Bone Cyst']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.royaninstitute.org', 'label': 'Royan Institute'}]}, 'descriptionModule': {'briefSummary': 'There are two types of bone cysts, unicameral and aneurismal. These cysts happen to anyone, but they are most commonly seen in children and young adults while their bones are still growing. Living with a bone cyst and determining treatment options depend on the type of cyst.\n\nNon-surgical treatments for unicameral bone cysts involves repeated X-rays in individuals who do not experience any symptoms.\n\nSurgical removal of a unicameral bone cyst is needed if it becomes especially painful, or the area of the bone starts to thin out. The investigators aim to assess the clinical efficacy and side effects of mesenchymal stem cells seeded on bone matrix in repairing bone cyst.', 'detailedDescription': 'Bone cysts are benign lesions usually discovered in children from age of 5 to 15 years. Treatment options include observation, corticosteroid injection and surgery. Sometimes the risk of surgery is comparable to the likelihood of fracture without treatment. In orthopedic surgery, bone chips , various types of ceramics, natural and synthetized bone mineral hydroxyapatite and tricalcium phosphate, as well as numerous polymers and co-polymers of alfa-hydroxy acids are used to perform as an osteoconductive and rarely osteoinductive factor to help bone formation.Some evidence demonstrated that bone marrow mesenchymal stem cells deposited on the surface of this constructs enhance its osteogenic differentiation. In this study the investigators seeds cultured bone marrow derived mesenchymal stem cells on bone matrix, to evaluate its therapeutic potential in repairing unicameral or aneurysmal bone cyst.This composite is placed in the bone cyst after its curettage during a surgery.Post-operation assessment is done by X-Ray examination and MRI at 1, 2, 6, and 12 months after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bone cyst diagnosed with MRI, CT-scan, or X-Ray\n* Intact cyst wall with high risk for fracture\n* Cysts with minimum diameter of 6mm\n* Diagnostic test performed on cyst fluid\n* Provided written consent form\n\nExclusion Criteria:\n\n* Patients with diagnosis of cancer\n* Patients enrolled in other clinical trial'}, 'identificationModule': {'nctId': 'NCT01207193', 'briefTitle': 'Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Bone Defects.', 'orgStudyIdInfo': {'id': 'Royan-Bone-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bone cyst', 'description': 'Patients with bone cyst defect are injected with mesenchymal cells.', 'interventionNames': ['Biological: cell injection']}], 'interventions': [{'name': 'cell injection', 'type': 'BIOLOGICAL', 'otherNames': ['cell transplantation'], 'description': 'injection of mesenchymal cells to bone cyst defect', 'armGroupLabels': ['bone cyst']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Royan Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Hamid Gourabi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'President of Royan Institute'}, {'name': 'Mohammad reza Baghban Eslami Nejad, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Scientific Board'}, {'name': 'Mohssen Emadeddin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopedic Investigator'}, {'name': 'Ahmad Vosough, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiologist investigator'}, {'name': 'Nasser Aghdami, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of regenerativ center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Hamid Gourabi/President of Royan Institute', 'oldOrganization': 'Royan Institute'}}}}