Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-26 @ 7:53 PM
Study NCT ID:
NCT06466850
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-06-14', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster University Osteoarthritis index (WOMAC)', 'timeFrame': '1, 3, and 6 months. The second injection is repeated in day 90 after first injection.', 'description': 'Filling out the WOMAC questionnaire, evaluating the measures related to knee function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'Present research focuses on the potential of exosomes, which are small vesicles secreted by mesenchymal stem cells (MSCs), as a therapeutic approach for osteoarthritis (OA).\n\nOA is a degenerative joint disorder characterized by the destruction of cartilage and loss of extracellular matrix. It\'s associated with pro-inflammatory cytokines and increased expression of matrix metalloproteinase (MMP) and "a disintegrin and metalloproteinase with thrombospondin motifs" (ADAMTS).\n\nMSCs have been explored as a new treatment for OA over the last decade1. It\'s suggested that the paracrine secretion of trophic factors, in which exosomes play a crucial role, contributes to the mechanism of MSC-based treatment of OA.\n\nExosomes derived from MSCs may suppress OA development. They carry bioactive molecules of the parental cells, including non-coding RNAs (ncRNAs) and proteins and anti-inflammatory factors. These exosomes have shown a significant impact on the modulation of various physiological behaviors of cells in the joint cavity.\n\nThis research provides hope for developing more effective and predictable methods of using MSC-derived exosomes for OA treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic history (for at least 3 months) of knee joint pain\n* Body mass index (BMI) between 21.5 and 29.5\n* Radiographically documented knee osteoarthritis of grades 1 to 3 (Kellgren-Lawrence (K-L) radiographic classification scale)\n\nExclusion Criteria:\n\n* Rheumatoid arthritis and other rheumatic diseases\n* Varus or valgus more than 10 degrees; lateral subluxation of the patella\n* Deformity at the joint levels or adjacent to the knee due to fracture or any other injury\n* Complete rupture of the ligament and meniscus leading to laxity or locking\n* Serious systemic, oncohematological, autoimmune diseases; history of severe allergy; serious failure of vital organs, inability to walk\n* Hyaluronic acid infiltration within the previous six months\n* Hemoglobin levels \\<10 g/dL;'}, 'identificationModule': {'nctId': 'NCT06466850', 'briefTitle': 'Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'The Efficacy of Allogenic Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients', 'orgStudyIdInfo': {'id': 'Isfahan med'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Patients with moderate to severe osteoarthritis, Kellgren-Lawrence grade 2,3 in both knees; accompanied by mild to moderate pain and swelling are included.', 'interventionNames': ['Biological: Exosome']}], 'interventions': [{'name': 'Exosome', 'type': 'BIOLOGICAL', 'otherNames': ['EVs'], 'description': 'intra-articular injection is suggested for two times: day 1and day 90', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Leila Dehghani, Assisstant Prof', 'role': 'CONTACT', 'email': 'l_dehghani2002@yahoo.com', 'phone': '36202020', 'phoneExt': '031'}, {'name': 'Masoud Soleimani, Prof', 'role': 'CONTACT', 'email': 'a70.leiladehghani@gmail.com', 'phone': '36202020', 'phoneExt': '031'}], 'facility': 'Leila Dehghani', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'centralContacts': [{'name': 'Leila Dehghani, Dr', 'role': 'CONTACT', 'email': 'l_dehghani2002@yahoo.com', 'phone': '36202020', 'phoneExt': '031'}, {'name': 'Masoud Soleimani, Prof', 'role': 'CONTACT', 'email': 'a70.leiladehghani@gmail.com', 'phone': '03136202020', 'phoneExt': '031'}], 'overallOfficials': [{'name': 'Leila Dehghani, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isfahan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Leila Dehghani', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}