Degenerative Disc Disease LumbarPhase 1/2AMBITIONNCT07858643
A Study of LDGraft In Single Level Lumbar Interbody Fusion
A Phase 1/2 study testing LDGraft in people with Degenerative Disc Disease Lumbar, run by Locate Bio Ltd at 2 sites in Georgia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Degenerative Disc Disease Lumbar
- What is being tested?
- LDGraft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesGeorgia
- Study dates
- 8 Apr 2026to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Georgia2 sites, 2 recruiting
- Recruiting
West Georgia Medical Center
Tbilisi, 44600
Study Coordinator
- Recruiting
JSC Georgian Clinics Kutaisi Referral Hospital
Tbilisi, 4600
Study Coordinator
About this study
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).
- Conditions
- Degenerative Disc Disease Lumbar
- Being tested
- LDGraft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDGraftCombination product
LDGraft (b-TCP / rhBMP-2) bone graft substitute
| Study group | Role | What they receive |
|---|---|---|
| LDGraft | Experimental | Not described Receives: Combination Product: LDGraft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary Surgical Intervention (SSI)
No index level secondary surgical intervention reported
Measured: 6-month and 12-month follow up
Radiographic Fusion
Radiographic fusion derived from bridging bone, angular motion and translational motion assessment via CT
Measured: 6-month and 12-month follow up
Oswestry Disability Index (ODI) Improvement
At least 15 point improvement in ODI compared to baseline
Measured: 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
Measured: 6-month and 12-month follow up
No Serious Device Related Adverse Events
Measured: 6-month and 12-month follow up
Secondary outcomes (7)
Visual Analog Score (VAS) Leg Improvement
20mm improvement compared to baseline
Measured: 6-week, 3-month, 6-month and 12-month follow up
Visual Analog Score (VAS) Back Improvement
20mm improvement compared to baseline
Measured: 6-week, 3-month, 6-month and 12-month follow up
Oswestry Disability Index (ODI) Change
Mean change over time intervals
Measured: 6-week, 3-month, 6-month and 12 month follow up
Visual Analog Score (VAS) Leg Change
Mean change over time intervals
Measured: 6-week, 3-month, 6-month and 12-month follow up
Visual Analog Score (VAS) Back Change
Mean change over time intervals
Measured: 6-week, 3-month, 6-month and 12-month follow up
Quality of Life & Satisfaction
Evaluation of Quality of Life \& Satisfaction survey results
Measured: 6-week, 3-month-, 6-month and 12-month follow up
Radiogrpahic Outcomes
Radiographic outcomes as defined by Image Review Charter
Measured: 6-week, 3-month, 6-month and 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start8 Apr 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc Disease LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Locate Bio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858643
- Sponsor's protocol ID
- CI-002
- Acronym
- AMBITION
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of LDGraft In Single Level Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT07858643
- Acronym / sponsor ID
- AMBITION / CI-002
- Conditions
- Degenerative Disc Disease Lumbar
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Locate Bio LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDGraft | Experimental | Combination Product: LDGraft |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LDGraftLDGraft (b-TCP / rhBMP-2) bone graft substitute | Combination product | LDGraft |
Primary outcome
Secondary Surgical Intervention (SSI)
Time frame: 6-month and 12-month follow up
No index level secondary surgical intervention reported
Radiographic Fusion
Time frame: 6-month and 12-month follow up
Radiographic fusion derived from bridging bone, angular motion and translational motion assessment via CT
Oswestry Disability Index (ODI) Improvement
Time frame: 6-month and 12-month follow up
At least 15 point improvement in ODI compared to baseline
No new or worsening lumbar spine neurological condition
Time frame: 6-month and 12-month follow up
No new or worsening lumbar spine neurological condition compared to baseline
No Serious Device Related Adverse Events
Time frame: 6-month and 12-month follow up
7 secondary outcomes
Visual Analog Score (VAS) Leg Improvement
Time frame: 6-week, 3-month, 6-month and 12-month follow up
Visual Analog Score (VAS) Back Improvement
Time frame: 6-week, 3-month, 6-month and 12-month follow up
Oswestry Disability Index (ODI) Change
Time frame: 6-week, 3-month, 6-month and 12 month follow up
Visual Analog Score (VAS) Leg Change
Time frame: 6-week, 3-month, 6-month and 12-month follow up
Visual Analog Score (VAS) Back Change
Time frame: 6-week, 3-month, 6-month and 12-month follow up
Quality of Life & Satisfaction
Time frame: 6-week, 3-month-, 6-month and 12-month follow up
Radiogrpahic Outcomes
Time frame: 6-week, 3-month, 6-month and 12-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LDGraft in people with Degenerative Disc Disease Lumbar, run by Locate Bio Ltd at 2 sites in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robyn Cochrane (+44115 7738447, rcochrane@locatebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary Surgical Intervention (SSI) (time frame: 6-month and 12-month follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.