Degenerative Disc DiseasePhase 1/2RESTORENCT06462729
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
A Phase 1/2 study testing LDGraft and Allograft Bone in people with Degenerative Disc Disease and Lumbar Disc Disease, run by Locate Bio Pty Ltd at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Degenerative Disc Disease, Lumbar Disc Disease, Spine Disease
- What is being tested?
- LDGraft and Allograft Bone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 Nov 2024to 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 (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;
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- scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule;
- herniated nucleus pulposus;
- facet joint degeneration/changes; and/or
- vacuum phenomenon.
- 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
- Participant is indicated for an ALIF approach to the lumbar spine
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 (Note: Up to two contiguous levels of decompression is acceptable)
- 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 1 (25% translation)
- Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered 'current')
- 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 (e.g. chronic systemic steroids) or receiving radiation therapy that is expected to continue for the duration of the study
- Body Mass Index > 35
- Insulin-dependent diabetes mellitus
- Osteopenia or osteoporosis of the spine, DEXA T score of ≤ -1.0
- 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)
- 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 (Diagnostic and Statistical Manual) 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, e.g., by the radiographic appearance of the fracture callus, deformity, malunion or nonunion
- Currently a prisoner
- Involved in active litigation relating to his/her spinal condition or workers compensation claimants.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Orthopaedics NorthEast
Fort Wayne, Indiana, 46825
Study Coordinator, 260-408-2643, tpawlik@orthone.com
Micah Smith, MD
- Recruiting
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37209
Ashley M. Campbell
Ryan D. Snowden, MD
- Recruiting
Pinehurst Surgical Clinic
Pinehurst, North Carolina, 28374
Nicole Goolsby
Daniel Williams, MD
Australia1 site, 1 recruiting
- Recruiting
Newcastle Private Hospital
Newcastle, New South Wales, 2305
Julie Charlton, +61 2 4941 8718, julie.charlton@healthscope.com.au
Mitchell Hansen, BSc MBBS PhD
About this study
Official title: A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
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).
Read the detailed description
This is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study which intends to demonstrate the safety of both LDGraft groups versus allograft during a single level ALIF procedure. This is a first in human (FIH) study.
The study will enroll patients with lumbar degenerative disc disease (DDD) requiring single level ALIF. The procedure will involve use of an intervertebral cage and fixation (plate and screws).
Upon successful completion of the Screening period and confirmation of eligibility the participant will allocated 3:3:2 to the LDGraft groups (investigational) or the allograft control group. Participants will be blinded to the treatment assigned however the surgical procedure and the post operative recovery will be managed in accordance with standard clinical practice for anterior lumbar interbody fusion.
- Being tested
- LDGraft, Allograft Bone
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral disc disease, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDGraftDevice
LDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
LDGraftDevice
LDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
Allograft BoneOther
Allograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws)
| Study group | Role | What they receive |
|---|---|---|
| LDGraft 0.5mg/cc | Experimental | Not described Receives: Device: LDGraft |
| LDGraft 1.0mg/cc | Experimental | Not described Receives: Device: LDGraft |
| Control Allograft Bone | Active comparator | Not described Receives: Other: Allograft Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Fusion
Radiographic fusion defined as evidence of bridging bone by CT scan
Measured: 12 months and 24 months
Secondary Surgical Intervention
No index level secondary surgical intervention
Measured: 12 months and 24 months
Oswestry Disability Index (ODI) Score
At least 15-point improvement in Oswestry Disability Index (ODI) compared to baseline
Measured: 12 months and 24 months
Neurological Condition
No new or worsening persistent lumbar spine neurological condition compared to baseline
Measured: 12 months and 24 months
Serious Device-Related Adverse Events
No serious device-related adverse events
Measured: 12 months and 24 months
Secondary outcomes (7)
Radiographic Outcomes
Radiographic outcomes including bridging bone, radiolucency, device condition, migration, subsidence, angular motion, and translational motion
Measured: 6 weeks, 3 months, 6 months, 12 months and 24 months
Visual Analog Score (VAS) Back
Improvement in the Visual Analog Score (VAS) back pain of 20mm compared to baseline
Measured: 6 weeks, 3 months, 6 months, 12 months and 24 months
Visual Analog Score (VAS) Change Back
Mean change in back VAS over time intervals
Measured: 6 weeks, 3 months, 6 months, 12 months and 24 months
Visual Analog Score (VAS) Leg
Improvement in the Visual Analog Score (VAS) worst leg of 20mm compared to baseline
Measured: 6 weeks, 3 months, 6 months, 12 months and 24 months
Visual Analog Score (VAS) Change Leg
Mean change in leg VAS over time intervals
Measured: 6 weeks, 3 months, 6 months, 12 months and 24 months
Oswestry Disability Index (ODI) Score
Improvement in ODI of 15 points compared to baseline
Measured: 6 weeks, 3 months, 6 months, 12 months and 24 months
Oswestry Disability Index (ODI) Change
Mean change in ODI over time intervals
Measured: 6 weeks, 3 months, 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start12 Nov 2024
- Primary completionDec 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 DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study which intends to demonstrate the safety of both LDGraft groups versus allograft during a single level ALIF procedure. The study will enrol patients with lumbar degenerative disc disease (DDD) requiring single level ALIF. After a screening period, qualified participants will be enrolled and randomized using a 3:3:2 ratio to receive the LDGraft or the control treatment-allograft bone via spinal surgery and will then complete the safety follow-up period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Locate Bio Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462729
- Sponsor's protocol ID
- CI-001
- Acronym
- RESTORE
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
- ClinicalTrials.gov ID
- NCT06462729
- Acronym / sponsor ID
- RESTORE / CI-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Locate Bio Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jun 2024 (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 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).
Detailed description
This is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study which intends to demonstrate the safety of both LDGraft groups versus allograft during a single level ALIF procedure. This is a first in human (FIH) study.
The study will enroll patients with lumbar degenerative disc disease (DDD) requiring single level ALIF. The procedure will involve use of an intervertebral cage and fixation (plate and screws).
Upon successful completion of the Screening period and confirmation of eligibility the participant will allocated 3:3:2 to the LDGraft groups (investigational) or the allograft control group. Participants will be blinded to the treatment assigned however the surgical procedure and the post operative recovery will be managed in accordance with standard clinical practice for anterior lumbar interbody fusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study which intends to demonstrate the safety of both LDGraft groups versus allograft during a single level ALIF procedure. The study will enrol patients with lumbar degenerative disc disease (DDD) requiring single level ALIF. After a screening period, qualified participants will be enrolled and randomized using a 3:3:2 ratio to receive the LDGraft or the control treatment-allograft bone via spinal surgery and will then complete the safety follow-up period.
| Arm | Type | Receives |
|---|---|---|
| LDGraft 0.5mg/cc | Experimental | Device: LDGraft |
| LDGraft 1.0mg/cc | Experimental | Device: LDGraft |
| Control Allograft Bone | Active comparator | Other: Allograft Bone |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 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 (L3 to S1) requiring fusion confirmed by patient history and radiographic imaging (CT/MRI/X-rays) with one or more of the following:
- 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 (Note: Up to two contiguous levels of decompression is acceptable)
- 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 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws) | Device | LDGraft 0.5mg/cc |
| LDGraftLDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws) | Device | LDGraft 1.0mg/cc |
| Allograft BoneAllograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws) | Other | Control Allograft Bone |
Primary outcome
Radiographic Fusion
Time frame: 12 months and 24 months
Radiographic fusion defined as evidence of bridging bone by CT scan
Secondary Surgical Intervention
Time frame: 12 months and 24 months
No index level secondary surgical intervention
Oswestry Disability Index (ODI) Score
Time frame: 12 months and 24 months
At least 15-point improvement in Oswestry Disability Index (ODI) compared to baseline
Neurological Condition
Time frame: 12 months and 24 months
No new or worsening persistent lumbar spine neurological condition compared to baseline
Serious Device-Related Adverse Events
Time frame: 12 months and 24 months
No serious device-related adverse events
7 secondary outcomes
Radiographic Outcomes
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Visual Analog Score (VAS) Back
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Visual Analog Score (VAS) Change Back
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Visual Analog Score (VAS) Leg
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Visual Analog Score (VAS) Change Leg
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Oswestry Disability Index (ODI) Score
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Oswestry Disability Index (ODI) Change
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
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 26 Aug 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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LDGraft and Allograft Bone in people with Degenerative Disc Disease and Lumbar Disc Disease, run by Locate Bio Pty Ltd at 4 sites in 2 countries.
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 13 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. 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 (+44 (0)115 784 0041, rcochrane@locatebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Fusion (time frame: 12 months and 24 months). 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 26 Aug 2026.