Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT01207661
Status:
COMPLETED
Last Update Posted:
2012-01-05
First Post:
2010-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Articular Cartilage Resurfacing With Mesenchymal Stem Cells In Osteoarthritis Of Knee Joint
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': 'D043182', 'term': 'Carboxylesterase'}], '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'}]}}, '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': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-02', 'studyFirstSubmitDate': '2010-09-06', 'studyFirstSubmitQcDate': '2010-09-22', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief', 'timeFrame': '6 months', 'description': 'evaluation the effect of Mesenchymal stem cell transplantation to decrease the patients pain'}], 'secondaryOutcomes': [{'measure': 'Pain relief', 'timeFrame': '6 months', 'description': 'decrease the patient pain in VAS scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mesenchymal cells', 'osteoarthritis', 'intra articular injection'], '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', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in terms of social and economic, are palliative and do not contemplate healing by regenerative therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded in vitro and may regenerate several damaged or injured tissues. In addition its has demonstrated that MSC are able to modulate immune responses and to control inflammation through its action on T lymphocytes. Preliminary studies in animal models, including one carried out in an equine by the investigators research group, confirms feasibility, safety and efficacy evidence proposed treatment protocol.This study is designed to evaluate therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.This study is designed to evaluate therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.', 'detailedDescription': 'Mesenchymal stem cells are pluripotent cells that can be obtained from various tissues .They have shown capabilities to differentiate into bone,cartilage,muscle,and adipose tissue, representing a new clinical strategy in regenerative medicine.An increasing number of reports have demonstrated effectiveness of percutaneous intra-articular infusion of MSCs in arthritic disease. In this study we perform a single intra articular injection of cultured mesenchymal stem cells in patients suffering from osteoarthritis, with the aim to assess its clinical safety and efficacy.Patients are assessed for response with MRI, X-Ray examination, WOMAC osteoarthritis index,VAS, and SF36 2,4,8 weeks and 6, and 12 months post infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients not pregnant or lactating.\n* Patients with a history of corticosteroids or on active therapy, will only be eligible for enrollment if corticosteroid use is suspended for 1 month prior cell therapy\n* Marcaine 0.75% و Lidocaine 4% test performed to be assure the exact location of the pain is related to the knee.\n* Diagnosis must be based on magnetic resonance imaging.\n* Both genders\n* Age:18-65 years\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.'}, 'identificationModule': {'nctId': 'NCT01207661', 'briefTitle': 'Articular Cartilage Resurfacing With Mesenchymal Stem Cells In Osteoarthritis Of Knee Joint', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Mesenchymal Stem Cells Transplantation for Articular Cartilage Resurfacing in Patient With Osteoarthritis of Knee Joint', 'orgStudyIdInfo': {'id': 'Royan-Bone-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesenchymal Injection', 'description': 'Intra Articular injection in Patients with osteoarthritis of knee joint', 'interventionNames': ['Biological: Mesenchymal Injection']}], 'interventions': [{'name': 'Mesenchymal Injection', 'type': 'BIOLOGICAL', 'otherNames': ['Cell Injection'], 'description': 'Intra Articular Injection of Mesenchymal cells to the knee joint', 'armGroupLabels': ['Mesenchymal Injection']}]}, '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': 'Mohammad reza Baghban Eslami Nejad, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Scientific Board'}, {'name': 'Mohssen Emadeddin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopadic Investigator'}, {'name': 'Nasser Aghdami, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Regeneration center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}