[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kolon TissueGene, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100527223","phase-1-study-to-determine-the-safety-and-tolerability-of-tg-c-in-subjects-with-back-pain-due-to-degenerative-disc-disease-100527223",false,"NCT06144970","Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease","A Phase I, Double-blind, Randomized, Sham-controlled, Dose-response, Study Evaluating the Safety and Tolerability of TG-C in Subjects With Chronic Discogenic Lumbar Back Pain Due to Degenerative Disc Disease at 6 and 12 Months","Inclusion Criteria:\n\n* Between the ages of \\>= 22 and \\\u003C= 70\n* Provides written informed consent before undergoing any study specific procedures\n* Chronic lower back pain for at least 6 months. Back pain twice as great as leg pain measured using NRS\n* VAS between \\>= 40 and \\\u003C= 90\n* ODI Index \\>30 and \\\u003C= 80\n* Inadequate response to at least one medication (e.g., NSAID, acetaminophen, muscle relaxant) and some form of formal physical therapy over a period of at least 6 months, within 6-9 months of screening.\n* Diagnosis of DDD from L1 to S1, confirmed by patient history and radiographic studies\n* Modified Pfirrmann score of 3-7 on MRI\n* With or without contained disc herniations of \\\u003C3 mm protrusion\n* If more than 1 degenerative disc is identified. PD must be performed 30 days prior and ensure only one level is the pain generator\n* BMI \\>15 and \\\u003C 30 kg\u002Fm2\n* Use birth control\n\nExclusion Criteria:\n\n* Co-morbid medical condition of the spine or upper extremities\n* Grade 2 or higher spondylolisthesis and type III Modic changes around target disc\n* Suspicion of full thickness annular tear at disc\n* History of endocrine or metabolic disorder\n* Rheumatoid or psoriatic arthritis\n* Compressive pathology due to stenosis or herniated or sequestered discs\n* Symptomatic involvement of more than one lumber disc\n* Intact disc bulge\u002Fprotrusion at \\>3 mm\n* Lumbar intervertebral foraminal stenosis\n* Previous surgery at the target disc level\n* Epidural or facet joint steroid, platelet rich plasma (PRP) or bone marrow concentrate (BMC) injections, or radio frequency ablation (RFA), within 6 months prior to baseline.\n* Pregnant\n* Presence of ferromagnetic implants\n* Involved in current or pending spinal litigations\n* Care is provided under a Worker's Compensation claim\n* Physical or mental conditions\n* 3 or more of the 5 Waddell signs\n* Positive screen for HIV\n* Immediate family member of other participating patients\n* Participated within 3 months or is concurrently enrolled in non-interventional research\n* Transient or has a history of any substance use disorder\n* Currently incarcerated\n* Investigator site personnel or immediate family or sponsor employee\n* On chronic anti-coagulation therapy or have confirmed coagulopathy\n* Tested positive on RCR testing at screening","ALL","22 Years","70 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this study is to evaluate the safety and tolerability of TG-C in subjects with chronic discogenic lumbar back pain due to degenerative disc disease. Participants will be administered a single intradiscal injection or subcutaneous injection for sham and followed up with in-clinic visits and telephone calls for 24 months.",[27],"Degenerative Disc Disease",[27],"NOT_YET_RECRUITING","2026-05-21",{"date":32,"type":33},"2026-05-27","ACTUAL",{"date":35,"type":21},"2027-01-19",{"date":37,"type":21},"2029-07-28",{"name":39,"class":40},"Kolon TissueGene, Inc.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100460468","phase-2-a-study-to-determine-the-safety-and-efficacy-of-tg-c-in-subjects-with-symptomatic-early-hip-osteoarthritis-100460468","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.","18 Years","80 Years",{"count":51,"type":21},255,[53],"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.",[56],"Degenerative Osteoarthritis",[58],"hip","2026-05-20",{"date":61,"type":33},"2026-05-22",{"date":63,"type":21},"2026-10",{"date":65,"type":21},"2027-10",{"name":39,"class":40},""]