[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613530":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":103,"collaborators":26,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":26,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":26,"enrollmentInfo":114,"targetDuration":26,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":26,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"DALIM TISSEN Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Group","EXPERIMENTAL","Group applied with CartiPRO",[13],"Drug: Synovian®",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Group applied with Synovian®",[19],"Device: CartiPRO",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","CartiPRO","Clinical subjects are enrolled after the investigator confirms eligibility, and subjects in the study group receive treatment Dalim Tissen's CartiPRO.\n\nIntra-articular medical device injection at baseline and Week 12; final assessment at Week 36.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Synovian®","Clinical subjects are enrolled after the investigator confirms eligibility, and subjects in the study group receive treatment Synovian®. Intra-articular medical device injection at baseline and Week 12; final assessment at Week 36.",[9],[33],{"name":34,"affiliation":35,"role":36},"Yong In, Ph.D","The Catholic University of Korea","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Hyunjin Bae Dream CIS","CONTACT","+82 2 2010 450","su-bin.lee@tigermedgrp.com",[44,60,72,82,92],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":26,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Seoul National University Bundang Hospital","RECRUITING","Seongnam-si","Bundang-gu","13620","South Korea",{"type":52,"coordinates":53},"Point",[54,55],127.13778,37.43861,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":26,"phoneExt":26,"email":26},"Yong Seuk Lee, Ph.D",{"facility":61,"status":46,"city":62,"state":48,"zip":63,"country":50,"countryCode":26,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"CHA Bundang Medical Center","Seoul","13496",{"type":52,"coordinates":65},[66,67],126.9784,37.566,{"lat":67,"lon":66},[70],{"name":71,"role":36,"phone":26,"phoneExt":26,"email":26},"Won Chul Choi, Ph.D",{"facility":73,"status":46,"city":62,"state":74,"zip":75,"country":50,"countryCode":26,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},"The Catholic University of Korea Eunpyeong St. Mary's Hospital","Eunpyeong-gu","03312",{"type":52,"coordinates":77},[66,67],{"lat":67,"lon":66},[80],{"name":81,"role":36,"phone":26,"phoneExt":26,"email":26},"In Jun Koh, Ph.D",{"facility":83,"status":46,"city":62,"state":84,"zip":85,"country":50,"countryCode":26,"cosmosGeoPoint":86,"geoPoint":88,"contacts":89},"Gachon University Gil Hospital","Namdong-gu","21565",{"type":52,"coordinates":87},[66,67],{"lat":67,"lon":66},[90],{"name":91,"role":36,"phone":26,"phoneExt":26,"email":26},"Jae-Ang Sim, Ph.D",{"facility":93,"status":46,"city":62,"state":94,"zip":95,"country":50,"countryCode":26,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"The Catholic University of Korea Seoul St. Mary's Hospital","Seochogu","06591",{"type":52,"coordinates":97},[66,67],{"lat":67,"lon":66},[100,101],{"name":34,"role":36,"phone":26,"phoneExt":26,"email":26},{"name":102,"role":36,"phone":26,"phoneExt":26,"email":26},"Man Soo Kim, Ph.D",{"type":104,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":115,"type":116},194,"ESTIMATED","INTERVENTIONAL",[119],"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.",[122,123,124,125,126],"Osteoarthritis","Knee Pain Arthritis","Cartilage Defects of the Knee","Knee Osteoarthritis","Degenerative Joint Disease of Knee","2026-01-15",{"date":129,"type":130},"2026-01-20","ACTUAL",{"date":132,"type":130},"2025-07-03",{"date":134,"type":116},"2026-10",{"name":5,"class":6},5]