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)

CTX0020-002

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).

2023-09-25

2024-08-01

2026-08-15

Not yet recruiting

Early phase I

300

Inclusion Criteria: * Age above 18 years * Male or female * 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) * Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures * Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination. Exclusion Criteria: * Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start * Unwillingness or inability to comply with study procedures * Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc. * Clinically active malignant disease * Previous thrombotic disorder * History of known pulmonary embolism or known secondary anti-phospholipid syndrome * Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur-containing products (e.g., DMSO) * Major trauma or surgery within 14 days of study treatment start * 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 * Alcohol, drug, or medication abuse within one year prior to study treatment start * Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study * Irreversible severe end-organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions * Patients or family history with a hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc. * History of long-term use of immunosuppressive agents * Organ transplants in the previous 6 months * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The Phase 2 study is an open-label, 6 arms, randomized, control group clinical study conducted in multiple clinical facilities.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Patients and evaluators', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2023-04-18