[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573040":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":35,"locations":30,"responsibleParty":43,"collaborators":45,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":30,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":30,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":71,"whyStopped":30,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":30},{"fullName":5,"class":6},"Nuwacell Biotechnologies Co., Ltd.","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"NCR100 injection","EXPERIMENTAL","Subjects will receive four injections of NCR100",[13],"Biological: NCR100",{"label":15,"type":16,"description":17,"interventionNames":18},"0.9% Normal saline","PLACEBO_COMPARATOR","Subjects will receive four injections of 0.9% Normal saline",[19],"Other: 0.9% Normal saline",{"label":21,"type":10,"description":22,"interventionNames":23},"NCR100 injection and 0.9% Normal saline","Subjects will receive two injections of 0.9% Normal saline and two injections of NCR100",[13,19],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","NCR100","Subjects will receive multiple intra-articular NCR100 injections.",[9,21],null,{"type":32,"name":15,"description":33,"armGroupLabels":34,"otherNames":30},"OTHER","Subjects will receive multiple intra-articular 0.9% Normal saline injections.",[15,21],[36,41],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Yanqiu Li, PHD","CONTACT","021-64369181","yqli@nuwacell.com",{"name":42,"role":38,"phone":39,"phoneExt":30,"email":30},"Changqing 021-64369181, PHD",{"type":44,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[46],{"name":47,"class":32},"Shanghai 6th People's Hospital","100573040","phase-1-a-study-of-ncr100-injection-for-the-treatment-of-knee-osteoarthritis-koa-100573040",false,"NCT06741098","A Study of NCR100 Injection for the Treatment of Knee Osteoarthritis（ KOA）","A Study to Evaluate the Safety, Tolerability and Efficacy of NCR100 Injection for the Treatment of Knee Osteoarthritis（ KOA）","Inclusion Criteria:\n\n* Subjects who understand and voluntarily sign the Informed Consent Form（ICF） before the enrolment;\n* Age: 40-65 years old, both genders;\n* Diagnosis of knee osteoarthritis based on American College of Rheumatology criteria;\n* Subjects with KOA who have persistent pain for more than six months\n* Kellgren-Lawrence grade: II-III\n\nExclusion Criteria:\n\n* Subjects previously diagnosed of secondary knee osteoarthritis, or those diagnosed with hip\u002Fankle joint disease requiring medical intervention;\n* Suffering from other diseases that impair knee function or joints;\n* Have received stem cell therapy;\n* Have knee injury history;\n* Experienced knee surgery, or plan to undergo knee surgery;\n* Received analgesics to relieve pain before Investigational Medicinal Product(IMP) injections;\n* Have used traditional Chinese medicine to treat KOA within 4 weeks;\n* Have used intra-articular injection of drugs to treat KOA within 12 weeks;\n* Received glucosamine,chondroitin sulfate, or diacetate therapy before investigational drug intervention within 12 weeks;\n* Subjects with acute phase of knee osteoarthritis;\n* Severe deformity of the knee;\n* Known or suspected allergy or a history of allergies;\n* Abnormal results of laboratory examination as follows: Hepatic Insufficiency （Alanine Aminotransferase\\>2xULN or Aspartate aminotransferase \\[ast\\]\\>2xULN) renal dysfunction (creatinine clearance rate ≤60ml\u002Fmin or blood urea nitrogen(BUN) \\> 2× ULN), Coagulation Defects (INR \\> 1.5) or severe hematological diseases (Grade 3 or above anemia \\[Hb \\\u003C 8 g\u002FdL\\], Grade 2 or above thrombocytopenia platelet count(PLT) \\\u003C 75×10\\^9\u002FL) ;\n* BMI≥30kg\u002Fm\\^2\n* Severe systemic infection or local knee joint infection;\n* Have received systemic glucocorticoid therapy before intervention or need to take systemic glucocorticoid therapy during the treatment;\n* Have a history of acute myocardial infarction or severe heart diseases,QT prolongation;\n* Subjects with peripheral or central nervous system disorders that may interfere assessments;\n* Have contraindications to Magnetic Resonance Imaging(MRI)\n* Subjects who are unable to walk on his own;\n* Subjects with alcohol\u002Fdrug addiction\u002Fabuse or mental disorders;\n* Pregnant or lactating, or unable to comply with contraceptives within 6 months after end of study;\n* Have participated in other clinical trials within 12 weeks before the screening;\n* Severe and poorly controlled comorbidities;","ALL","40 Years","65 Years",{"count":59,"type":60},162,"ESTIMATED","INTERVENTIONAL",[63,64],"PHASE1","PHASE2","This clinical study is to investigate the safety and efficacy of NCR100 injection in subjects with knee osteoarthritis (KOA). It contains two parts dose-escalating, and blind random study in adult KOA subjects.",[67],"Knee Osteoarthritis",[69,70],"KOA","Mesenchymal Stromal Cells","NOT_YET_RECRUITING","2024-12-16",{"date":74,"type":75},"2024-12-18","ACTUAL",{"date":77,"type":60},"2025-02-20",{"date":79,"type":60},"2028-11-15",{"name":5,"class":6}]