[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460468":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":42,"locations":49,"responsibleParty":50,"collaborators":49,"id":52,"slug":49,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":49,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":49,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":72,"whyStopped":49,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":49},{"fullName":5,"class":6},"Kolon TissueGene, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Treatment (TG-C)","ACTIVE_COMPARATOR","TG-C at 1.0 x 10e7 cells per single 2 mL intraarticular injection",[13],"Biological: TG-C",{"label":15,"type":10,"description":16,"interventionNames":17},"Active Treatment 2 (TG-C)","TG-C at 3.0 x 10e6 cells per single 2 mL intraarticular injection",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo Control (Normal Saline)","PLACEBO_COMPARATOR","Normal saline, single 2 mL intraarticular injection",[23],"Biological: Placebo Control",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","TG-C","2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1.",[9,15],[31],"TissueGene-C",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Placebo Control","2 mL normal saline injection",[19],[37],"Normal Saline",[39],{"name":40,"affiliation":5,"role":41},"Moon Jong Noh, PhD","STUDY_CHAIR",[43],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Diana Halim, MS","CONTACT","(301) 921-6000","187","dhalim@tissuegene.com",null,{"type":51,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100460468",false,"NCT05276011","A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteoarthritis","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects With Symptomatic Early Hip Osteoarthritis","Inclusion Criteria:\n\n* Aged 18 to 80 years old\n* The subject has a diagnosis of Grade ≤2 primary OA of the target hip\n* Pain ≥ 40 on VAS scale\n* The subject has groin pain that is elicited by hip rotation on physical examination\n* No history of significant organ system disorders.\n* Body mass index (BMI) \\\u003C40 kg\u002Fm2\n* Systolic blood pressure of 100 to 160 mmHg and diastolic blood pressure of 60 to 90 mmHg.\n* Using birth control\n* Written informed consent\n\nExclusion Criteria:\n\n* The subject exhibits severe symptoms in the target hip that result in difficulty or an inability to walk.\n* The subject has severe hip OA ipsilateral to the target hip.\n* Previous cartilage transplantation procedure to the injured cartilage surface.\n* Major injury to the target hip within 12 months of screening.\n* Active dermal ulcer or infection in the proximity of the target hip within 1 month before screening.\n* The subject has had surgery on the target hip within the last 6 months.\n* Total hip replacement surgery or other surgery on the target hip in the next 12 months.\n* MRI indicates bone marrow infiltration, fracture, osteonecrosis\u002Fbone infarct, osteochondritis dissecans, tumor, moderate to severe dysplasia, avascular necrosis, post-traumatic arthritis, transient osteoporosis, slipped-cap femoral epiphysis, juvenile idiopathic arthritis, or axial juvenile spondyloarthritis.\n* Hip conditions including but not limited to any autoimmune or infectious cause for arthritis; metabolic joint disease; neuropathic disorders, groin pain from non-orthopedic sources, or tumors, congestive heart failure, or chronic kidney disease.\n* Uncontrolled diabetes based on a hemoglobin A1c (HbA1c) value \\>8% at the screening Visit.\n* Increased risk for post-procedure bleeding or post-procedure infection.\n* Ongoing infectious disease, including, but not limited to, HIV, hepatitis C, or current or prior hepatitis B.\n* Cognitive impairment that would limit his\u002Fher ability to provide informed consent or to complete assessments and questionnaires.\n* 1 year history of drug or alcohol abuse.\n* Contraindication to or cannot undergo MRI.\n* Active malignancy within the last 5 years.\n* Pregnant or is lactating.\n* Taken steroidal or NSAIDs within 14 days before the Baseline Visit\n* Using topical analgesics on the target hip\n* Receiving chronic narcotic treatment at screening.\n* Received any injection to the target hip within the 3 months before the Baseline Visit.\n* Taking antiplatelet or anticoagulants.\n* Participated in an investigational study within 13 weeks before the Screening Visit or in the next 25 months.\n* Unable to comply with the requisite study follow-up and all of the follow-up office visits.","ALL","18 Years","80 Years",{"count":62,"type":63},255,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects with Symptomatic Early Hip Osteoarthritis. TG-C will be administered to the target hip by a single ultrasound (or fluoroscopy)-guided, intra-articular injection with image capture showing correct injection of study drug into the femoroacetabular joint. Patients will be followed for 12 months for safety and efficacy.",[69],"Degenerative Osteoarthritis",[71],"hip","NOT_YET_RECRUITING","2026-05-20",{"date":75,"type":76},"2026-05-22","ACTUAL",{"date":78,"type":63},"2026-10",{"date":80,"type":63},"2027-10",{"name":5,"class":6}]