[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603518":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":7,"responsibleParty":19,"collaborators":7,"id":21,"slug":22,"hasResults":23,"nctId":24,"briefTitle":25,"officialTitle":26,"acronym":27,"eligibilityCriteria":28,"healthyVolunteers":23,"sex":29,"minAge":30,"maxAge":31,"enrollmentInfo":7,"targetDuration":7,"studyType":32,"phases":7,"briefSummary":33,"conditions":34,"keywords":37,"overallStatus":51,"whyStopped":7,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":56,"locationsCount":7},{"fullName":5,"class":6},"Creative Medical Technology Holdings Inc","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DRUG","CELZ-201-DDT","CELZ-201-DDT is administered via intramuscular injection.\n\nDosing, administration, and follow-up will be determined by the treating physician in accordance with the EA authorization and medical judgment. Safety monitoring will be performed during and after treatment, and all serious adverse events will be reported to the FDA and IRB per applicable regulations.",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Creative Medical Technology","CONTACT","(702) 588-1890","expandedaccess@creativemedicaltechnology.com",{"type":20,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100603518","celz-201-ddt-for-the-treatment-of-chronic-lower-back-pain-100603518",false,"NCT07137559","CELZ-201-DDT for the Treatment of Chronic Lower Back Pain","Expanded Access Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain","ADAPT","Inclusion Criteria:\n\n* Confirmed diagnosis of chronic lower back pain due to degenerative disc disease.\n* No comparable or satisfactory alternative therapy available. Unable to participate in the ongoing CELZ-201-DDT clinical trial. Informed consent provided.\n\nExclusion Criteria:\n\n* Any medical condition that poses an unacceptable risk or would interfere with treatment safety or evaluation.\n* Known hypersensitivity to any component of the investigational product.\n\nHow to Request Access:\n\n* Contact the Expanded Access Coordinator to confirm eligibility and discuss feasibility.\n* Complete and submit FDA Form 3926 to the appropriate FDA review division.\n* Obtain IRB review (may be expedited or post-treatment for emergency use). Coordinate drug shipment and treatment schedule.","ALL","18 Years","80 Years","EXPANDED_ACCESS","CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain.",[35,36],"Chronic Back Pain","Degenerative Disc Disease Lumbar",[11,38,39,40,41,42,43,44,45,46,47,48,49,50],"Allogeneic Umbilical Cord Sub-Epithelial Cell-Derived Mesenchymal Stromal Cells","Mesenchymal Stromal Cells (MSC)","Chronic Lower Back Pain","Degenerative Disc Disease (DDD)","Lumbar Degeneration","Chronic Pain","Expanded Access","Single Patient IND","Emergency Use IND","Non-Emergency Use IND","Compassionate Use","Regenerative Medicine","Stem Cell Therapy","AVAILABLE","2025-08-14",{"date":54,"type":55},"2025-08-22","ACTUAL",{"name":5,"class":6}]