Degenerative Lumbar SpondylolisthesisPhase 1/2NCT05961956
Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis
A Phase 1/2 study testing NVDX3 in people with Degenerative Lumbar Spondylolisthesis, run by Novadip Biosciences at 1 site in Luxembourg.
Trial summary
Prospective, single arm, single-center clinical study to test NVDX3 in patients suffering from low grade one level degenerative lumbar (L1 - S1) spondylolisthesis. NVDX3 will be implanted during a single surgical intervention. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Lumbar Spondylolisthesis
- What is being tested?
- NVDX3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteLuxembourg
- Study dates
- 12 Oct 2023to 18 Apr 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥18 years to ≤80 years.
- Patient diagnosed with symptomatic DLS with confirmed:
- Classification: Meyerding grade I or II DLS
- One vertebral segment within the lumbar region from L1-S1
- Availability of AP and LAT X-ray, MRI and/or CT scan at which the diagnosis was made.
- The estimated volume of targeted disc space to be filled (both inside and around the interbody cage) should not exceed 10cc.
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- Clinically meaningful pain or neurological symptoms with or without claudication confirmed by a preoperative ODI score >30, which have been unresponsive to a minimum of 3 consecutive months of structured conservative medical management (including at least pain medication, activity modification, and daily exercise).
- Patient is eligible for surgery by minimally invasive or open transforaminal lumbar interbody fusion (TLIF)3.
- Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent.
Who cannot join
- History of previously attempted spinal fusion at the same vertebral level, or at a level immediately adjacent to the level intended to undergo the spondylodesis. Decompressive surgery alone (laminectomy) is not an exclusion criterion.
- Patient with a BMI of ≥35.
- Presence of clinically significant infection at the target implant site or presence of any systemic infection.
- History of allergic reaction or any anticipated hypersensitivity to any of the following:
- Osteosynthesis materials (eg.cage, screws, rods,…),
- Anesthetic agents,
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- Components of the NVDX3 implant
- Presence of any auto-immune disease, with exception of well controlled diabetes type-1 or II, or auto-immune thyroid disorders.
- Positive serology for human immunodeficiency virus (HIV), HBcAb and/or HBsAg.
- Presence of an active tumor.
- Documented metabolic bone disease or any disorder, such as but not limited to high-risk osteoporosis, that could interfere with the bone healing and bone metabolism.
- Documented disease limiting mobility and functional assessments.
- Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulants, immunosuppressants or immunotherapy.
- Excessive smoking or history of chronic alcohol or drug abuse within the 12 months prior to screening
- Use of any investigational drug within 60 days prior to screening.
- Pregnant women or women of childbearing potential (WOCBP) not agreeing to use effective an effective method of birth control4 during the course of the study. Note: WOCBP including peri-menopausal women who have had a menstrual period within 1 year prior to surgery have to have a negative pregnancy test before entering in the study.
- Any other psychosocial, mental and physical condition which, in the opinion of the investigator, could interfere with the trial conduct, the patient's compliance or influence interpretation of the results.
- Patient with historically elevated radiation exposure levels that could in the opinion of the investigator introduce unacceptable radiation risks for the patient, when being accumulated with the radiological examinations planned in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof-of-concept Study With NVDX3, an Osteogenic Implant of Human Allogenic Origin, in the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis by Interbody Spine Fusion in Adults.
Prospective, single arm, single-center clinical study to test NVDX3 in patients suffering from low grade one level degenerative lumbar (L1 - S1) spondylolisthesis. NVDX3 will be implanted during a single surgical intervention.
Read the detailed description
This is a prospective, single arm, single-center PoC study in adult patients, suffering from a degenerative lumbar (L1-S1) spondylolisthesis, treated by spondylodesis in which NVDX3, an osteogenic implant from human allogeneic origin is used. The screening and implant surgery visits will be used as the reference timepoint respectively for the clinical and the radiological efficacy outcome evaluations.
As per standard of care, patients with DLS are followed up to 12 months post-intervention. In the context of this trial, patient safety and IMP efficacy will be followed up to 24 months post-implant surgery.
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Being tested
- NVDX3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVDX3Drug
NVDX3 is implanted during a single surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| NVDX3 osteogenic implant | Experimental | Not described Receives: Drug: NVDX3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Description of all SAEs and NVDX3 related AEs
Measured: Up to 24 months post implant surgery
Secondary outcomes (14)
Safety: all acute SAEs and NVDX3 related AEs
Description of all acute SAEs and NVDX3 related AEs
Measured: Between screening (V1) and 6 weeks post-IS (V4)
Safety: all SAEs and NVDX3 related AEs
Description of all SAEs and NVDX3 related AEs
Measured: Beyond 6 weeks (V4 excluded) until 12 months post-IS
Safety: all SAEs and NVDX3 related AEs
Description of all SAEs and NVDX3 related AEs
Measured: Beyond 12 months (V7 excluded) until 24 months post-IS
Safety: TEAEs
Description of Treatment Emergent AEs (TEAEs)
Measured: a. Between screening and week 6 (V4 included) b. Between week 6 (V4 excluded) till month 12 (V7 included) c. Between month 12 (V7 excluded) till month 24 (V9 included) d. Full study duration
Safety: related and unexpected (S)AEs
Description of related and unexpected (S)AEs
Measured: Between screening (v1) till 24 months post-IS
Safety: AESI
Description of AE of Special Interest (AESI)
Measured: Between screening (v1) till 24 months post-IS
Safety: Lab data
Description of lab data
Measured: Between screening (v1) till 24 months post-IS
Safety: vital signs: physiological parameters
Description of vital signs: body temperature, pulse rate, respiratory rate and blood pressure
Measured: Between screening (v1) till 24 months post-IS
Efficacy: Radiological assessments
Evaluate presence of cortical and trabecular bone formation
Measured: a. 4 and 12 months post-IS based on CT compared to Hospital Discharge image acquisition and b. 24-months post-IS based on X-rays compared to the first post-operative X-ray acquisitions taken at 6 weeks post-IS
Efficacy: Radiological assessments
Evaluate presence of spinal fusion (Interbody/disc and facet joint fusion status)
Measured: a. 4 and 12 months post-IS based on CT compared to Hospital Discharge image acquisition and b. 24-months post-IS based on X-rays compared to the first post-operative X-ray acquisitions taken at 6 weeks post-IS
Efficacy: Radiological assessments
Measure the average disc height variations based on CT
Measured: At Hospital Discharge, 4 and 12 months post-IS
Efficacy: Clinical assessments: investigator questionnaire
Physician rated Clinical Global Impression scale (CGI)
Measured: At hospital discharge, 6 weeks, 4-, 6-, 12-, 18- and 24-months post-IS
Efficacy: Clinical assessments: patient questionnaire
Patient reported Functional assessments using the ODI
Measured: At hospital discharge, 6 weeks, 4-, 6-, 12-, 18- and 24-months post-IS
Efficacy: Clinical assessments: patient questionnaire
Patient reported Numeric rating scale (NRS) for pain
Measured: At hospital discharge, 6 weeks, 4-, 6-, 12-, 18- and 24-months post-IS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start12 Oct 2023
- Primary completion18 Apr 2026 (estimated)
- Study completion18 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar SpondylolisthesisStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novadip Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David BREUSKIN, MD, Principal investigator, Centre Hospitalier du Luxembourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961956
- Sponsor's protocol ID
- NVDX3-CLN02
- Other IDs
- 2022-002771-11
- Status last verified
- Dec 2025
- First submitted
- 11 Jul 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept Study With NVDX3, an Osteogenic Implant of Human Allogenic Origin, in the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis by Interbody Spine Fusion in Adults.
- ClinicalTrials.gov ID
- NCT05961956
- Acronym / sponsor ID
- NVDX3-CLN02
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Novadip BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 18 Apr 2026 (estimated)
- Study completion
- 18 Apr 2026 (estimated)
- First posted
- 27 Jul 2023 (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.
Prospective, single arm, single-center clinical study to test NVDX3 in patients suffering from low grade one level degenerative lumbar (L1 - S1) spondylolisthesis. NVDX3 will be implanted during a single surgical intervention.
Detailed description
This is a prospective, single arm, single-center PoC study in adult patients, suffering from a degenerative lumbar (L1-S1) spondylolisthesis, treated by spondylodesis in which NVDX3, an osteogenic implant from human allogeneic origin is used. The screening and implant surgery visits will be used as the reference timepoint respectively for the clinical and the radiological efficacy outcome evaluations.
As per standard of care, patients with DLS are followed up to 12 months post-intervention. In the context of this trial, patient safety and IMP efficacy will be followed up to 24 months post-implant surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NVDX3 osteogenic implant | Experimental | Drug: NVDX3 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients aged ≥18 years to ≤80 years.
- Patient diagnosed with symptomatic DLS with confirmed:
- The estimated volume of targeted disc space to be filled (both inside and around the interbody cage) should not exceed 10cc.
- Clinically meaningful pain or neurological symptoms with or without claudication confirmed by a preoperative ODI score >30, which have been unresponsive to a minimum of 3 consecutive months of structured conservative medical management (including at least pain medication, activity modification, and daily exercise).
- Patient is eligible for surgery by minimally invasive or open transforaminal lumbar interbody fusion (TLIF)3.
Key exclusion criteria (18 listed)
- History of previously attempted spinal fusion at the same vertebral level, or at a level immediately adjacent to the level intended to undergo the spondylodesis. Decompressive surgery alone (laminectomy) is not an exclusion criterion.
- Patient with a BMI of ≥35.
- Presence of clinically significant infection at the target implant site or presence of any systemic infection.
- History of allergic reaction or any anticipated hypersensitivity to any of the following:
- Presence of any auto-immune disease, with exception of well controlled diabetes type-1 or II, or auto-immune thyroid disorders.
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 |
|---|---|---|
| NVDX3NVDX3 is implanted during a single surgical intervention. | Drug | NVDX3 osteogenic implant |
Primary outcome
Primary Safety Endpoint
Time frame: Up to 24 months post implant surgery
Description of all SAEs and NVDX3 related AEs
14 secondary outcomes
Safety: all acute SAEs and NVDX3 related AEs
Time frame: Between screening (V1) and 6 weeks post-IS (V4)
Safety: all SAEs and NVDX3 related AEs
Time frame: Beyond 6 weeks (V4 excluded) until 12 months post-IS
Safety: all SAEs and NVDX3 related AEs
Time frame: Beyond 12 months (V7 excluded) until 24 months post-IS
Safety: TEAEs
Time frame: a. Between screening and week 6 (V4 included) b. Between week 6 (V4 excluded) till month 12 (V7 included) c. Between month 12 (V7 excluded) till month 24 (V9 included) d. Full study duration
Safety: related and unexpected (S)AEs
Time frame: Between screening (v1) till 24 months post-IS
Safety: AESI
Time frame: Between screening (v1) till 24 months post-IS
Safety: Lab data
Time frame: Between screening (v1) till 24 months post-IS
Safety: vital signs: physiological parameters
Time frame: Between screening (v1) till 24 months post-IS
Efficacy: Radiological assessments
Time frame: a. 4 and 12 months post-IS based on CT compared to Hospital Discharge image acquisition and b. 24-months post-IS based on X-rays compared to the first post-operative X-ray acquisitions taken at 6 weeks post-IS
Efficacy: Radiological assessments
Time frame: a. 4 and 12 months post-IS based on CT compared to Hospital Discharge image acquisition and b. 24-months post-IS based on X-rays compared to the first post-operative X-ray acquisitions taken at 6 weeks post-IS
Efficacy: Radiological assessments
Time frame: At Hospital Discharge, 4 and 12 months post-IS
Efficacy: Clinical assessments: investigator questionnaire
Time frame: At hospital discharge, 6 weeks, 4-, 6-, 12-, 18- and 24-months post-IS
Efficacy: Clinical assessments: patient questionnaire
Time frame: At hospital discharge, 6 weeks, 4-, 6-, 12-, 18- and 24-months post-IS
Efficacy: Clinical assessments: patient questionnaire
Time frame: At hospital discharge, 6 weeks, 4-, 6-, 12-, 18- and 24-months post-IS
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 24 Dec 2025.
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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. This study is not recruiting at the moment.
David BREUSKIN, MD principal investigator
Centre Hospitalier du Luxembourg
1 site 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 NVDX3 in people with Degenerative Lumbar Spondylolisthesis, run by Novadip Biosciences at 1 site in Luxembourg.
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 9 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: Up to 24 months post implant surgery). 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 24 Dec 2025.