[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"DALIM TISSEN Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100613530","long-term-study-of-cartipro-for-knee-pain-due-to-osteoarthritis-or-cartilage-damage-100613530",false,"NCT07267793","Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage","Long-term Efficacy and Safety of CartiPRO Injection to Alleviate Knee Pain in Patients With Osteoarthritis and\u002For Diverse Cartilage Defects: a Multicenter, Single-blind, Randomized, Non-inferiority, Sponsor Initiated Trial","Inclusion Criteria\n\n* Age 19 years and older\n* Diagnosed with unilateral or bilateral knee osteoarthritis according to American College of Rheumatology (ACR) criteria, with at least 3 of the following 6 features:\n\n  * Age ≥50 years\n  * Morning stiffness \\\u003C30 minutes\n  * Crepitus on active motion\n  * Bony tenderness\n  * Bony enlargement\n  * No palpable warmth\n* Radiographic evidence of Kellgren-Lawrence grade I, II, or III osteoarthritis within 6 months prior to screening or at screening visit\n* Weight-bearing pain Visual Analogue Scale (VAS) score ≥40 mm in at least one knee joint at screening\n* Able to walk without assistive devices (walkers or canes), OR if using a walking aid routinely for past 6 months, able to continue using the same device throughout the study\n* Able to understand and complete efficacy assessment questionnaires\n* Willing and able to provide written informed consent\n\nExclusion Criteria\n\n* Body Mass Index (BMI) ≥32 kg\u002Fm²\n* Chronic inflammatory joint disease (e.g., rheumatoid arthritis)\n* Inflammatory joint disease (e.g., septic arthritis)\n* Secondary knee osteoarthritis due to ochronosis, hemochromatosis, or systemic disease\n* Painful musculoskeletal conditions (e.g., Sudeck's atrophy, Paget's disease, herniated intervertebral disc)\n* Polyarticular disease with severe osteoarthritis in other joints (e.g., hip) that may affect knee pain evaluation\n* Radiographic evidence of definite loss of patellofemoral joint space\n* Moderate to severe joint effusion confirmed by positive patellar tap test or equivalent\n* History of myocardial infarction, congestive heart failure, other serious cardiac disease, or uncontrolled hypertension (≥140\u002F90 mmHg despite treatment with ≥3 antihypertensive agents)\n* History of autoimmune disease\n* Active infection requiring parenteral antibiotics\n* History of psychiatric disorder or epilepsy\n* Cancer diagnosis within 5 years prior to screening\n* Uncontrolled type 1 or type 2 diabetes mellitus (HbA1c \\>7%)\n* Surgical procedures (including arthroscopy) on target knee within 1 year (surgery on contralateral knee or hip may be exclusionary if it could affect target knee assessment)\n* Intra-articular corticosteroid injection into target knee within 12 weeks\n* Systemic corticosteroid use within 4 weeks (topical and inhaled corticosteroids permitted)\n* Surgery or radiation therapy to knee joint within 12 weeks, or not fully recovered from side effects\n* Immunosuppressive therapy (e.g., Cyclosporine A, Azathioprine) within 6 weeks\n* Intra-articular injections (e.g., hyaluronic acid) into knee joint within 6 months\n* Prohibited concomitant medications within 2 weeks (unless washout period is adequate)\n* Anticoagulants (e.g., warfarin, NOACs), antiplatelet agents (e.g., aspirin \\>100 mg\u002Fday, clopidogrel; low-dose aspirin ≤100 mg\u002Fday permitted), thrombolytic agents (e.g., urokinase, alteplase), or Vitamin E \\>1000 IU\u002Fday within 2 weeks (unless adequate washout)\n* Habitual use (≥3 months) of psychoactive drugs or narcotic analgesics that may affect pain perception\n* History of cell therapy or gene therapy to target joint\n* Planned cell therapy or gene therapy to target joint\n* Abnormal laboratory values at screening:\n* ALT, AST, BUN, or serum creatinine \\>2× upper limit of normal\n* Engaged in high-intensity aerobic or heavy anaerobic exercise that may affect the knee joint\n* Dermatological disease at injection site or site deemed unsuitable for injection\n* Ligament instability of Grade II or higher in target knee (Grade 0: none; Grade I: 0-5 mm; Grade II: 5-10 mm; Grade III: \\>10 mm)\n* Known hypersensitivity to investigational product or its components\n* Pregnant or breastfeeding women\n* Women or men of childbearing potential unwilling to use acceptable contraception during study (acceptable methods: intrauterine device, tubal ligation, sterilization surgery, condom or diaphragm with spermicide, natural family planning)\n* Participation in another clinical trial within 4 weeks\n* Cognitive impairment or dementia preventing informed consent\n* Any other condition that makes the subject unsuitable for study participation per investigator judgment","ALL","19 Years",{"count":19,"type":20},194,"ESTIMATED","INTERVENTIONAL",[23],"NA","This clinical trial aims to evaluate and compare the efficacy and safety of CartiPRO, an approved intra-articular atelocollagen injection, versus Synovian injection for the relief of knee pain in patients with knee osteoarthritis. The investigational device is administered intra-articularly, with a second injection given 24 weeks after the first dose. Primary and secondary endpoints include changes in pain scores (VAS), functional assessments (WOMAC, SF-36), and safety evaluations over a 36-week period.",[26,27,28,29,30],"Osteoarthritis","Knee Pain Arthritis","Cartilage Defects of the Knee","Knee Osteoarthritis","Degenerative Joint Disease of Knee","RECRUITING","2026-01-15",{"date":34,"type":35},"2026-01-20","ACTUAL",{"date":37,"type":35},"2025-07-03",{"date":39,"type":20},"2026-10",{"name":41,"class":42},"DALIM TISSEN Co., Ltd.","INDUSTRY",5,""]