Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-30 @ 1:53 AM
Study NCT ID:
NCT04314661
Status:
UNKNOWN
Last Update Posted:
2022-09-28
First Post:
2020-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'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': 'D001182', 'term': 'Arthroscopy'}, {'id': 'D000089282', 'term': 'Secretome'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D055442', 'term': 'Metabolome'}, {'id': 'D008660', 'term': 'Metabolism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-12-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-25', 'studyFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '1 month after injection', 'description': 'To asses pain score, score 1(good)-10(worst)'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '3 month after injection', 'description': 'To asses pain score, score 1(good)-10(worst)'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '6 month after injection', 'description': 'To asses pain score, score 1(good)-10(worst)'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index', 'timeFrame': '1 month after injection', 'description': 'To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index', 'timeFrame': '3 month after injection', 'description': 'To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index', 'timeFrame': '6 month after injection', 'description': 'To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.'}], 'secondaryOutcomes': [{'measure': 'Laboratory Asessment', 'timeFrame': '2 weeks after injection', 'description': 'COMP, MMP-13, IL-6'}, {'measure': 'Laboratory Asessment', 'timeFrame': '1 month after injection', 'description': 'COMP, MMP-13, IL-6'}, {'measure': 'Laboratory Asessment', 'timeFrame': '3 months after injection', 'description': 'COMP, MMP-13, IL-6'}, {'measure': 'Magnetic Resonance Imaging (MRI) T2 mapping', 'timeFrame': '6 month after injection', 'description': 'MRI T2 mapping is used for cartilage evaluation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Allogeneic Mesenchymal Stem Cells', 'Umbilical Cord', 'Conditioned Medium'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy of Umbilical Cord Mesenchymal Stem Cell and secretome between arthroscopy and without arthroscopy intervention in OA patients. This study has 4 arms namely Arthroscopy + Booster, Arthroscopy + Pre-conditioning, Non-Arthroscopy + Booster, Non-Arthroscopy + Pre-conditioning.', 'detailedDescription': 'The study subjects each group amounted to 5 patients suffering from osteoarthritis. Patients are evaluated before, and 1,3,6 months after injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 55-70 years\n* Suffering from grade 2-3 OA was identified by two observers who differed accordingly Kellgren-Lawrence research scale\n* Absence of local or general infections\n* Haematological and biochemical analysis without significant changes being made cause contraindications\n* Patients can understand the nature of the study\n* Written informed consent is given to patients\n\nExclusion Criteria:\n\n* Patients are not willing to obey the study protocol\n* There are signs of infection or positive serology for HIV, hepatitis and syphilis\n* There is a history of cancer both in the family and yourself and the value of the examination tumour marker exceeds normal limits\n* There is a congenital disease that causes significant deformity of the knee can interfere with cell applications and interpret results\n* Articular injection of the knee by any drug during the previous 3 months\n* Participate in any clinical trial or treatment 30 days before the study\n* Other conditions may, according to medical criteria, not support participation in this research\n* Patients are subordinates or low ranking members'}, 'identificationModule': {'nctId': 'NCT04314661', 'acronym': 'OA', 'briefTitle': 'Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT. Prodia Stem Cell Indonesia'}, 'officialTitle': 'Innovative Osteoarthritis Therapy Using Combination of Mesenchymal Stem Cell (MSC) and Conditioned Medium (CM): A Comparative Study on Arthroscopy and Non-Arthroscopy', 'orgStudyIdInfo': {'id': 'CT/OA/02/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arthroscopy + Booster', 'description': 'After arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection.', 'interventionNames': ['Biological: Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome']}, {'type': 'EXPERIMENTAL', 'label': 'Arthroscopy + Pre-Conditioning', 'description': 'After arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection.', 'interventionNames': ['Biological: Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome']}, {'type': 'EXPERIMENTAL', 'label': 'Non Arthroscopy + Booster', 'description': 'Without arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection.', 'interventionNames': ['Biological: Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome']}, {'type': 'EXPERIMENTAL', 'label': 'Non Arthroscopy + Pre-Conditioning', 'description': 'Without arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection.', 'interventionNames': ['Biological: Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome']}], 'interventions': [{'name': 'Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome', 'type': 'BIOLOGICAL', 'description': 'After Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.', 'armGroupLabels': ['Arthroscopy + Booster']}, {'name': 'Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome', 'type': 'BIOLOGICAL', 'description': 'After Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.', 'armGroupLabels': ['Arthroscopy + Pre-Conditioning']}, {'name': 'Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome', 'type': 'BIOLOGICAL', 'otherNames': ['Secretome'], 'description': 'Without Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.', 'armGroupLabels': ['Non Arthroscopy + Booster']}, {'name': 'Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome', 'type': 'BIOLOGICAL', 'description': 'Without Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.', 'armGroupLabels': ['Non Arthroscopy + Pre-Conditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10410', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Yanuarso, dr', 'role': 'CONTACT', 'email': 'dryanuarso73@gmail.com', 'phone': '08170147000'}, {'name': 'Viana', 'role': 'CONTACT', 'email': 'rahmawativiana@gmail.com', 'phone': '081317128172'}], 'facility': 'Gatot Soebroto Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Yanuarso Yanuarso, Master', 'role': 'CONTACT', 'email': 'dryanuarso73@gmail.com', 'phone': '081317128172'}, {'name': 'Cynthia Sartika, Doctor', 'role': 'CONTACT', 'email': 'c.sartika@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT. Prodia Stem Cell Indonesia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}