[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527223":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":48,"centralContacts":53,"locations":36,"responsibleParty":60,"collaborators":36,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":36,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":36,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":82,"whyStopped":36,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":36},{"fullName":5,"class":6},"Kolon TissueGene, Inc.","INDUSTRY",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Treatment 1","ACTIVE_COMPARATOR","Low dose TG-C 1.5 x 10e6 cells",[13],"Biological: TG-C Low Dose",{"label":15,"type":10,"description":16,"interventionNames":17},"Active Treatment 2","Middle dose TG-C 5.0 x 10e6 cells",[18],"Biological: TG-C Mid Dose",{"label":20,"type":10,"description":21,"interventionNames":22},"Active Treatment 3","High dose TG-C 1.5 x 10e7 cells",[23],"Biological: TG-C High Dose",{"label":25,"type":26,"description":27,"interventionNames":28},"Sham Control","SHAM_COMPARATOR","single subcutaneous injection of normal saline",[29],"Biological: Sham Control",[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BIOLOGICAL","TG-C High Dose","High Dose - 1 mL of the combined TG-C cells",[20],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"TG-C Mid Dose","Middle Dose - A volume of 2 mL CS10 and 1 mL combined TG-C cells. 1.0 mL volume of the mixed TG-C cells is injected",[15],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"TG-C Low Dose","Low Dose - A volume of 9 mL CS10 and 1 mL combined TG-C cells. 1.0 mL volume of the mixed TG-C cells is injected",[9],{"type":32,"name":25,"description":46,"armGroupLabels":47,"otherNames":36},"Single subcutaneous injection of normal saline",[25],[49],{"name":50,"affiliation":51,"role":52},"Moon Jong Noh, PhD","Kolon TissueGene","STUDY_CHAIR",[54],{"name":55,"role":56,"phone":57,"phoneExt":58,"email":59},"Diana M Halim, MS","CONTACT","(301) 921-6000","187","dhalim@tissuegene.com",{"type":61,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","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":73,"type":74},24,"ESTIMATED","INTERVENTIONAL",[77],"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.",[80],"Degenerative Disc Disease",[80],"NOT_YET_RECRUITING","2026-05-21",{"date":85,"type":86},"2026-05-27","ACTUAL",{"date":88,"type":74},"2027-01-19",{"date":90,"type":74},"2029-07-28",{"name":5,"class":6}]