[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Locate Bio Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100658956","phase-1-a-study-of-ldgraft-in-single-level-lumbar-interbody-fusion-100658956",false,"NCT07858643","A Study of LDGraft In Single Level Lumbar Interbody Fusion","AMBITION","Inclusion Criteria:\n\n* Skeletally mature adults ≥22 and ≤80 years at the time of surgery\n* Willing and able to give written informed consent and comply with study protocol and postoperative management program\n* Degenerative disc disease of the lumbosacral spine in one level requiring fusion confirmed by patient history and radiographic imaging\n* Preoperative Oswestry Disability Index score ≥ 35\n* Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months\n\nExclusion Criteria:\n\n* Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar spine\n* More than one level lumbar spine level requiring fusion\n* Three or more contiguous lumbar spine levels requiring decompression\n* Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides.\n* Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women\n* Presence of active malignancy\n* Requires bone growth stimulation in the lumbar spine\n* Active local or systemic infection\n* Spondylolisthesis greater than Grade 2 (50% translation)\n* Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping)\n* Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis\n* Any medical condition requiring treatment with any drug known to potentially interfere with bone\u002Fsoft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study\n* Body Mass Index \\> 40\n* Insulin-dependent diabetes mellitus\n* Osteopenia or osteoporosis of the spine\n* Any secondary causes of osteoporosis or other conditions known to adversely affect osteogenesis\n* Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs\n* Current or recent history of chemical\u002Falcohol abuse or dependency using standard medical definition of DSM-5 code\n* In the opinion of the investigator, the participant has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the product\n* Radiographically compromised vertebral bodies at the index level due to current or past trauma\n* Currently a prisoner\n* Involved in active litigation relating to his\u002Fher spinal condition or workers compensation claimants.","ALL","22 Years","80 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The objective of the study is to evaluate the safety and effectiveness of LDGraft (investigational device) when applied in a lumbar interbody fusion procedure in the treatment of patients with lumbar Degenerative Disc Disease (DDD).",[28],"Degenerative Disc Disease Lumbar","RECRUITING","2026-09-30",{"date":32,"type":33},"2026-10-05","ACTUAL",{"date":35,"type":33},"2026-04-08",{"date":37,"type":21},"2027-12",{"name":39,"class":40},"Locate Bio Ltd","INDUSTRY",2,""]