Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-31 @ 6:17 AM
Study NCT ID:
NCT01499056
Status:
COMPLETED
Last Update Posted:
2011-12-26
First Post:
2011-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, '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': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-21', 'studyFirstSubmitDate': '2011-12-17', 'studyFirstSubmitQcDate': '2011-12-21', 'lastUpdatePostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'swelling of hip joint', 'timeFrame': '2 months', 'description': 'Evaluatin the swelling of hip joint by physical examination after intra articular injection.'}, {'measure': 'deterioration of joint function', 'timeFrame': '2 months', 'description': 'Evaluation deterioration of joint function by physical examination after intra articular cell injection.'}, {'measure': 'skin allergic reaction', 'timeFrame': '1 week', 'description': 'Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.'}, {'measure': 'Respiratory reaction', 'timeFrame': '1 week', 'description': 'Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.'}], 'secondaryOutcomes': [{'measure': 'Quantitative changes in pain intensity', 'timeFrame': '2 months', 'description': 'Evaluation Quantitative changes in pain intensity measured by Visual Analogue Scale after intra articular cell injection 2 months after cell transplantation in compare with base line (before injection)'}, {'measure': 'physical function improvement', 'timeFrame': '2 months', 'description': 'Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score.'}, {'measure': 'subchondral bone edema', 'timeFrame': '2 months', 'description': 'Evaluation the subchondral bone edema by MRI'}, {'measure': 'cartilage thickness', 'timeFrame': '2 months', 'description': 'measuring the cartilage thickness after cell transplantation by MRI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['osteoarthritis', 'hip joint', 'mesenchymal stem cell'], 'conditions': ['Hip Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '26058927', 'type': 'DERIVED', 'citation': 'Emadedin M, Ghorbani Liastani M, Fazeli R, Mohseni F, Moghadasali R, Mardpour S, Hosseini SE, Niknejadi M, Moeininia F, Aghahossein Fanni A, Baghban Eslaminejhad R, Vosough Dizaji A, Labibzadeh N, Mirazimi Bafghi A, Baharvand H, Aghdami N. Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. Arch Iran Med. 2015 Jun;18(6):336-44.'}]}, 'descriptionModule': {'briefSummary': 'Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant problems. First-line of management for patient with osteoarthritis consists of weight reduction, education, and analgesic medication. If necessary, invasive treatment like total hip replacement are performed for the patient. The objective of this study was to assess the safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip osteoarthritis', 'detailedDescription': 'This is a phase one clinical study designed to investigate the safety of intra-articular injection of cultured autologous BM-MSCs in patients with severe hip osteoarthritis candidate for total hip replacement. All subjects will undergo bone marrow aspiration. Autologous MSCs will be extracted and cultured for 4 weeks. Patients will receive intra-articular injection of cultured MSCs under the guide of fluoroscopy. Paraclinical studies (X-Ray and MRI) will be done before and 6 months after treatment. Pain relief and functional improvement of the joint will be assessed by VAS, WOMAC, and Harris Hip Score questionnaire before treatment, and 2 and 6 months after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoarthritis diagnosed by MRI\n* End stage osteoarthritis candidate for total hip replacement\n\nExclusion Criteria:\n\n* Pregnancy or lactating\n* Positive tests for HIV, HCV, HBV\n* Active neurologic disorder\n* End organ damage\n* Uncontrolled endocrine disorder'}, 'identificationModule': {'nctId': 'NCT01499056', 'briefTitle': 'Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Evaluation the Side Effect of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Osteoarthritis of Hip Joint', 'orgStudyIdInfo': {'id': 'Royan-Bone-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hip osteoarthritis', 'description': 'The patients with hip joint osteoarthritis who underwent cell injection', 'interventionNames': ['Biological: stem cell injection']}], 'interventions': [{'name': 'stem cell injection', 'type': 'BIOLOGICAL', 'description': 'intra articular inection of mesenchymal stem cell', 'armGroupLabels': ['hip osteoarthritis']}]}, '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': 'Head of Royan Institute'}, {'name': 'Nasser Aghdami, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of Royan Cell therapy Center'}, {'name': 'Mohsen Emadeddin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'scientist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}