Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Recruiting Phase 1/2

LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

NCT06462729 · tracked via the Priya Life Science USA tracker
Sponsor
Locate Bio Pty Ltd
Phase
Phase 1/2
Started
2024-11-12
Last updated
2026-08-26

Condition(s) studied

Degenerative Disc DiseaseLumbar Disc DiseaseSpine DiseaseLumbar Spine Degeneration

Investigational drug(s) / intervention(s)

LDGraftLDGraftAllograft Bone

LDGraft: LDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)

LDGraft: LDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)

Allograft Bone: Allograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws)

Study summary

The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of patients with lumbar degenerative disc disease (DDD).

Eligibility

Sex
ALL
Min age
22 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Skeletally mature adults ≥22 and ≤80 years at the time of surgery 2. Willing and able to give written informed consent and comply with study protocol and postoperative management program 3. Degenerative disc disease of the lumbosacral spine in one level (L3 to S1) requiring fusion confirmed by patient history and radiographic imaging (CT/MRI/X-rays) with one or more of the following: * instability (as defined by ≥3mm translation or ≥5° angulation); * osteophyte formation of facet joints or vertebral endplates; * decreased disc height, on average by \>2mm, but dependent upon the spinal level; * scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule; * herniated nucleus pulposus; * facet joint degeneration/changes; and/or * vacuum phenomenon. 4. Preoperative Oswestry Disability Index score ≥ 35 5. Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months 6. Participant is indicated for an ALIF approach to the lumbar spine Exclusion Criteria: 1. Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar spine 2. More than one level lumbar spine level requiring fusion 3. Three or more contiguous lumbar spine levels requiring decompression (Note: Up to two contiguous levels of decompression is acceptable) 4. 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. 5. Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women 6. Presence of active malignancy 7. Requires bone growth stimulation in the lumbar spine 8. Active local or systemic infection 9. Spondylolisthesis greater than Grade 1 (25% translation) 10. Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered 'current') 11. 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 12. Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids) or receiving radiation therapy that is expected to continue for the duration of the study 13. Body Mass Index \> 35 14. Insulin-dependent diabetes mellitus 15. Osteopenia or osteoporosis of the spine, DEXA T score of ≤ -1.0 16. Any secondary causes of osteoporosis (e.g. chronic liver or kidney disease, uncontrolled hyper- or hypothyroidism, type I or type II diabetes mellitus, gastrointestinal malabsorption syndromes) or other conditions known to adversely affect osteogenesis (e.g. Paget's disease, Ehlers-Danlos syndrome or osteogenesis imperfecta) 17. Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs; 18. Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 (Diagnostic and Statistical Manual) code 19. 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 20. Radiographically compromised vertebral bodies at the index level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, deformity, malunion or nonunion 21. Currently a prisoner 22. Involved in active litigation relating to his/her spinal condition or workers compensation claimants.

Primary outcome measure(s)

  • Radiographic Fusion — 12 months and 24 months
    Radiographic fusion defined as evidence of bridging bone by CT scan
  • Secondary Surgical Intervention — 12 months and 24 months
    No index level secondary surgical intervention
  • Oswestry Disability Index (ODI) Score — 12 months and 24 months
    At least 15-point improvement in Oswestry Disability Index (ODI) compared to baseline
  • Neurological Condition — 12 months and 24 months
    No new or worsening persistent lumbar spine neurological condition compared to baseline
  • Serious Device-Related Adverse Events — 12 months and 24 months
    No serious device-related adverse events

Trial sites (4)

FacilityCityRegionStatus
Orthopaedics NorthEast Fort Wayne Indiana Recruiting
Pinehurst Surgical Clinic Pinehurst North Carolina Recruiting
Tennessee Orthopaedic Alliance Nashville Tennessee Recruiting
Newcastle Private Hospital Newcastle New South Wales Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06462729 on ClinicalTrials.gov ↗ ← All trials in the USA