Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT01436058
Status:
COMPLETED
Last Update Posted:
2011-09-19
First Post:
2011-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Ankle Joint Osteoartritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D033581', 'term': 'Stem Cell Transplantation'}], 'ancestors': [{'id': 'D017690', 'term': 'Cell Transplantation'}, {'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': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-16', 'studyFirstSubmitDate': '2011-09-14', 'studyFirstSubmitQcDate': '2011-09-16', 'lastUpdatePostDateStruct': {'date': '2011-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety', 'timeFrame': '6 months', 'description': 'Evaluate Safety of intra-articular injection of autologous cultured mesenchymal stem cells in patients with ankle osteoarthritis (time frame : baseline, 2 months, 6 months)by filling the check list of side effects'}], 'secondaryOutcomes': [{'measure': 'pain', 'timeFrame': '6 months', 'description': 'evaluation the pain reduction in patients with ankle joint osteoarthritis after stem cell transplantation by filling the SF36'}, {'measure': 'physical function', 'timeFrame': '6 months', 'description': 'evaluation the ability of patient to standing,walking,climb the steps after stem cell transplantation.'}, {'measure': 'defect', 'timeFrame': '6 months', 'description': 'evaluation regeneration of ankle joint by serial MRI after stem cell transplantation based on changing the size of articular defect'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['side effect', 'mesenchymal stem cell', 'ankle', 'osteoarthritis'], 'conditions': ['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.'}], 'seeAlsoLinks': [{'url': 'http://www.royaninstitute.org/cmsen/index.php', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Ankle osteoarthritis is a joint condition which results from damage and loss of the cartilage in a joint. Treatment options for ankle osteoarthritis are usually aimed at controlling pain and limiting motion that provokes the pain. Nonsurgical treatment approaches are tried first. If unsuccessful, surgical options are considered. Stem cell therapy is one of the therapeutic options that can repair the damaged cartilage. Bone marrow derived mesenchymal stem cells have showed the capacity of bone and cartilage regeneration.', 'detailedDescription': 'In this clinical study the investigators aim to investigate the safety of intra-articular injection of cultured autologous bone marrow derived mesenchymal stem cells (BM-MSCs) to the ankle joint in patients with severe ankle osteoarthritis. Patients will undergo bone marrow aspiration and will receive cultured BM-MSCs one month later. Patients will be assessed clinically with scoring system (FAO, VAS, WOMAC) preoperatively as well as 2 and 6 months postoperative to measure pain reduction and joint function improvement. Paraclinical studies (X-Ray and MRI) will be performed before 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 ankle 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': 'NCT01436058', 'briefTitle': 'Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Ankle Joint Osteoartritis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Phase 1 Study of Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Patients With Ankle Joint Osteoarteritis', 'orgStudyIdInfo': {'id': 'Royan-Bone-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stem cell recipient', 'description': 'patients with ankle joint osteoarthritis', 'interventionNames': ['Biological: mesenchymal stem cell']}], 'interventions': [{'name': 'mesenchymal stem cell', 'type': 'BIOLOGICAL', 'otherNames': ['stem cell transplantation'], 'description': 'intraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis', 'armGroupLabels': ['stem cell recipient']}]}, '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': 'orthopedic scientists'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}