A Study of LDGraft In Single Level Lumbar Interbody Fusion (AMBITION)

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).

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease Lumbar
• Intervention / Treatment: Combination product: LDGraft

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Robyn Cochrane; Phone Number: +44115 7738447; Email: rcochrane@locatebio.com

Study Locations

• Georgia
  • Tbilisi, Georgia, 44600
    • Recruiting
    • West Georgia Medical Center
    • Contact: Study Coordinator
  • Tbilisi, Georgia, 4600
    • Recruiting
    • JSC Georgian Clinics Kutaisi Referral Hospital
    • Contact: Study Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Skeletally mature adults ≥22 and ≤80 years at the time of surgery
• Willing and able to give written informed consent and comply with study protocol and postoperative management program
• Degenerative disc disease of the lumbosacral spine in one level requiring fusion confirmed by patient history and radiographic imaging
• Preoperative Oswestry Disability Index score ≥ 35
• Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months

Exclusion Criteria:

• Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar spine
• More than one level lumbar spine level requiring fusion
• Three or more contiguous lumbar spine levels requiring decompression
• 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.
• Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women
• Presence of active malignancy
• Requires bone growth stimulation in the lumbar spine
• Active local or systemic infection
• Spondylolisthesis greater than Grade 2 (50% translation)
• Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping)
• 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
• Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study
• Body Mass Index > 40
• Insulin-dependent diabetes mellitus
• Osteopenia or osteoporosis of the spine
• Any secondary causes of osteoporosis or other conditions known to adversely affect osteogenesis
• Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs
• Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 code
• 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
• Radiographically compromised vertebral bodies at the index level due to current or past trauma
• Currently a prisoner
• Involved in active litigation relating to his/her spinal condition or workers compensation claimants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LDGraft	Combination product: LDGraft; LDGraft (b-TCP / rhBMP-2) bone graft substitute

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Surgical Intervention (SSI)	No index level secondary surgical intervention reported	6-month and 12-month follow up
Radiographic Fusion	Radiographic fusion derived from bridging bone, angular motion and translational motion assessment via CT	6-month and 12-month follow up
Oswestry Disability Index (ODI) Improvement	At least 15 point improvement in ODI compared to baseline	6-month and 12-month follow up
No new or worsening lumbar spine neurological condition	No new or worsening lumbar spine neurological condition compared to baseline	6-month and 12-month follow up
No Serious Device Related Adverse Events		6-month and 12-month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Score (VAS) Leg Improvement	20mm improvement compared to baseline	6-week, 3-month, 6-month and 12-month follow up
Visual Analog Score (VAS) Back Improvement	20mm improvement compared to baseline	6-week, 3-month, 6-month and 12-month follow up
Oswestry Disability Index (ODI) Change	Mean change over time intervals	6-week, 3-month, 6-month and 12 month follow up
Visual Analog Score (VAS) Leg Change	Mean change over time intervals	6-week, 3-month, 6-month and 12-month follow up
Visual Analog Score (VAS) Back Change	Mean change over time intervals	6-week, 3-month, 6-month and 12-month follow up
Quality of Life & Satisfaction	Evaluation of Quality of Life & Satisfaction survey results	6-week, 3-month-, 6-month and 12-month follow up
Radiogrpahic Outcomes	Radiographic outcomes as defined by Image Review Charter	6-week, 3-month, 6-month and 12-month follow up

Collaborators and Investigators

• Sponsor: Locate Bio Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 22, 2026
• First Submitted That Met QC Criteria: September 30, 2026
• First Posted (Actual): October 5, 2026

Study Record Updates

• Last Update Posted (Actual): October 5, 2026
• Last Update Submitted That Met QC Criteria: September 30, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CI-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No