Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-26 @ 5:52 PM
Study NCT ID:
NCT01210950
Status:
COMPLETED
Last Update Posted:
2014-04-28
First Post:
2010-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007870', 'term': 'Leg Length Inequality'}, {'id': 'D002145', 'term': 'Callosities'}], 'ancestors': [{'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D043182', 'term': 'Carboxylesterase'}, {'id': 'D011935', 'term': 'Reagins'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}], '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': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, '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': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-24', 'studyFirstSubmitDate': '2010-09-25', 'studyFirstSubmitQcDate': '2010-09-28', 'lastUpdatePostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect of mesenchymal cell transplantation to decrease limb inequal', 'timeFrame': '6 months', 'description': 'evaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening and decrease limb inequal'}], 'secondaryOutcomes': [{'measure': 'improve life quality', 'timeFrame': '12 months', 'description': 'mesenchymal cells transplantation improve patients life quality'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['distraction', 'osteogenesis', 'limb length discrepancy', 'callus'], 'conditions': ['Leg Length Inequality']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.royaninstitute.org', 'label': 'Royan Institute'}]}, 'descriptionModule': {'briefSummary': 'Limb-length discrepancy can be due to many causes. These are divided into three groups: congenital (from birth), developmental (from a childhood disease or injury that slows or damages the growth plates), and posttraumatic (from a fracture that leads to shortening of the bone ends). There are three ways to equalize the limb-length discrepancy: use a shoe lift, shorten the long leg, lengthen the short leg. Most patients do not like wearing a lift greater than 2 cm (3/4 in). For discrepancies greater than 2 cm but less than 5 cm (2 in), shortening of the long leg can be considered, especially for tall persons. For growing children, this can be easily accomplished with a small, minimally invasive, uncomplicated procedure called epiphysiodesis.The investigators aim to evaluate if injection of bone marrow derived mesenchymal stem cells can shorten the treatment period by acceleration of bone regeneration during distraction osteogenesis.', 'detailedDescription': 'Distraction osteogenesis has been widely utilized to treat leg length discrepancy, deformity, nonunion, osteomyelitis, and bone loss. It has been found that most difficult conditions can be resolved with this method. In this study the aim is to observe if mesenchymal stem cell transplantation can enhance new bone formation during distraction osteogenesis.Patients undergo bone distraction , and about 2-3 weeks after distraction mesenchymal stem cell are injected at the callus site. In the case of large bone gap, mesenchymal stem cells are seeded on bone matrix and then placed in the bone gap. Each patient is assessed at interval time of 1 month for 6 months post surgery by X-Ray and at month 6 post surgery by computed tomography(CT) scans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both gender\n* patient with limb-length discrepancy\n* Age:18-65\n\nExclusion Criteria:\n\n* Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease\n* Known allergic reaction to components of study treatment and/or study injection procedure\n* Patients infected with hepatitis B,C or HIV\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01210950', 'briefTitle': 'Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Autologous Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Distraction Osteogenesis in Patients With Limb-length Discrepancy', 'orgStudyIdInfo': {'id': 'Royan-Bone-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cell and RPR recepients', 'description': 'mesenchymal cells and plasma reach protein are injected to the callus center of short limb', 'interventionNames': ['Biological: cell and RPR injection']}], 'interventions': [{'name': 'cell and RPR injection', 'type': 'BIOLOGICAL', 'otherNames': ['cell therapy'], 'description': 'mesenchymal cells and Plasma reach Protein are injected to the callus center', 'armGroupLabels': ['cell and RPR recepients']}]}, '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': 'Board scientific'}, {'name': 'Mohssen Emadeddin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopadic Investigator'}, {'name': 'Nasser Aghdami, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Regenerative center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}