Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-30 @ 1:54 PM
Study NCT ID:
NCT04448106
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-18
First Post:
2020-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients and evaluators'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The Phase 2 study is an open-label, 6 arms, randomized, control group clinical study conducted in multiple clinical facilities.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of patients achieve visual analog scale (VAS) pain improvement above 30%, 50% and 70% from the baseline', 'timeFrame': '12 months', 'description': 'efficacy'}, {'measure': 'Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline', 'timeFrame': '12 months', 'description': 'efficacy'}], 'primaryOutcomes': [{'measure': 'the frequency and nature of adverse events occurring during the study based on the annualized rate of all AdMSC-associated adverse events (AEs) in all subjects.', 'timeFrame': '12 months', 'description': 'safety'}, {'measure': 'Any organ damage or safety concerns determined by SMAC 20 blood test.', 'timeFrame': '12 months', 'description': 'Safety'}], 'secondaryOutcomes': [{'measure': 'Change of Knee injury and Osteoarthritis Outcome Score (KOOS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients', 'timeFrame': '12 months', 'description': 'efficacy'}, {'measure': 'Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients', 'timeFrame': '12 months', 'description': 'efficacy'}, {'measure': 'Change of Hip disability and Osteoarthritis Outcome Score (HOOS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients', 'timeFrame': '12 months', 'description': 'efficacy'}, {'measure': 'Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients', 'timeFrame': '12 months', 'description': 'efficacy'}, {'measure': 'Change of the American Shoulder and Elbow Surgeons Shoulder Score (ASES, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients', 'timeFrame': '12 month', 'description': 'efficacy'}, {'measure': 'Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients', 'timeFrame': '12 months', 'description': 'efficacy'}, {'measure': 'changes in joint images (X-ray or MRI) from the baseline', 'timeFrame': '12 months', 'description': 'efficacy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autologous Adipose-derived Stem Cells (AdMSCs)'], 'conditions': ['Osteoarthritis, Knee', 'Osteoarthritis, Hip', 'Osteoarthritis Shoulder']}, 'descriptionModule': {'briefSummary': 'This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age above 18 years\n* Male or female\n* Subjects in study group must have banked AdMSCs at Celltex (already passed communicable disease screen tests for HIV, syphilis and Hepatitis B and C during banking stage)\n* Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures\n* Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination.\n\nExclusion Criteria:\n\n* Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start\n* Unwillingness or inability to comply with study procedures\n* Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.\n* Clinically active malignant disease\n* Previous thrombotic disorder\n* History of known pulmonary embolism or known secondary anti-phospholipid syndrome\n* Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur-containing products (e.g., DMSO)\n* Major trauma or surgery within 14 days of study treatment start\n* Mental condition rendering the subject (or the subject's legally acceptable representative\\[s\\]) unable to understand the nature, scope and possible consequences of the study\n* Alcohol, drug, or medication abuse within one year prior to study treatment start\n* Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study\n* Irreversible severe end-organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions\n* Patients or family history with a hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.\n* History of long-term use of immunosuppressive agents\n* Organ transplants in the previous 6 months\n* Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study"}, 'identificationModule': {'nctId': 'NCT04448106', 'acronym': 'AdMSCs', 'briefTitle': 'Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celltex Therapeutics Corporation'}, 'officialTitle': 'Clinical Study for Subjects With Osteoarthritis of Knees, Hips, and Shoulders Using a Combination of Intravenous Infusions With Intra-articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)', 'orgStudyIdInfo': {'id': 'CTX0020-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 2 Arm 1 - OA Knee', 'description': '50 subjects receive two doses of 2.0-2.86 x 10\\^6 cells/kg on days 0 and 6 via intravenous infusion.\n\nOn day 3, each subject will receive a single dose of 1.0-2.86 x 10\\^6 cells/kg via intra-articular injection into the injured joint.', 'interventionNames': ['Biological: Celltex- AdMSCs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2 Arm 2 OA Knee', 'description': 'Control group- 50 subjects receive three doses of 2.0-2.86 x 10\\^6 cells/kg on day 0, 3, and 6 via intravenous infusion', 'interventionNames': ['Biological: Celltex- AdMSCs']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Arm 3 - OA Hip', 'description': '50 subjects receive two doses of 2.0-2.86 x 10\\^6 cells/kg on days 0 and 6 via intravenous infusion.\n\nOn day 3, each subject will receive a single dose of 1.0-2.86 x 10\\^6 cells/kg via intra-articular injection into the injured joint.', 'interventionNames': ['Biological: Celltex- AdMSCs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2 Arm 4 - OA Hip', 'description': 'Control group- 50 subjects receive three doses of 2.0-2.86 x 10\\^6 cells/kg on day 0, 3, and 6 via intravenous infusion', 'interventionNames': ['Biological: Celltex- AdMSCs']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Arm 5 - OA Shoulder', 'description': '50 subjects receive two doses of 2.0-2.86 x 10\\^6 cells/kg on days 0 and 6 via intravenous infusion.\n\nOn day 3, each subject will receive a single dose of 1.0-2.86 x 10\\^6 cells/kg via intra-articular injection into the injured joint.', 'interventionNames': ['Biological: Celltex- AdMSCs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2 Arm 6 - OA Shoulder', 'description': 'Control group- 50 subjects receive three doses of 2.0-2.86 x 10\\^6 cells/kg on day 0, 3, and 6 via intravenous infusion', 'interventionNames': ['Biological: Celltex- AdMSCs']}], 'interventions': [{'name': 'Celltex- AdMSCs', 'type': 'BIOLOGICAL', 'otherNames': ['AdMSCs'], 'description': "Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue", 'armGroupLabels': ['Phase 2 Arm 1 - OA Knee', 'Phase 2 Arm 2 OA Knee', 'Phase 2 Arm 3 - OA Hip', 'Phase 2 Arm 4 - OA Hip', 'Phase 2 Arm 5 - OA Shoulder', 'Phase 2 Arm 6 - OA Shoulder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77098', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Sally McGahee, BS', 'role': 'CONTACT', 'email': 'smcgahee@celltexbank.com', 'phone': '713-590-1000', 'phoneExt': '147'}], 'facility': 'Stanley C Jones', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Jane Young', 'role': 'CONTACT', 'email': 'jyoung@celltexbank.com', 'phone': '7135901000'}], 'overallOfficials': [{'name': 'Derek W Guillory, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Root Causes Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celltex Therapeutics Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}