A Phase 1/2 interventional study of NVDX3 in Degenerative Lumbar Spondylolisthesis, sponsored by Novadip Biosciences. Active, not recruiting at 1 site in Luxembourg. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Novadip Biosciences · Phase 1/2, Interventional, and Treatment
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.
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.
227 studies on the registry are indexed under Spondylolisthesis; 43 are open to participants now.
This study's enrollment of 5 is below the median of 60 across 143 interventional studies indexed under Spondylolisthesis.
Browse Spondylolisthesis studies →Novadip Biosciences is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient diagnosed with symptomatic DLS with confirmed:
Exclusion Criteria:
History of allergic reaction or any anticipated to any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: NVDX3
NVDX3 is implanted during a single surgical intervention.
Primary Safety Endpoint
Description of all SAEs and NVDX3 related AEs
Time frame: Up to 24 months post implant surgery
Safety: all acute SAEs and NVDX3 related AEs
Description of 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
Description of 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
Description of all SAEs and NVDX3 related AEs
Time frame: Beyond 12 months (V7 excluded) until 24 months post-IS
Safety: TEAEs
Description of Treatment Emergent AEs (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
Description of related and unexpected (S)AEs
Time frame: Between screening (v1) till 24 months post-IS
Safety: AESI
Description of AE of Special Interest (AESI)
Time frame: Between screening (v1) till 24 months post-IS
Safety: Lab data
Description of lab data
Time frame: 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
Time frame: Between screening (v1) till 24 months post-IS
Efficacy: Radiological assessments
Evaluate presence of cortical and trabecular bone formation
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
Evaluate presence of spinal fusion (Interbody/disc and facet joint fusion status)
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
Measure the average disc height variations based on CT
Time frame: At Hospital Discharge, 4 and 12 months post-IS
Efficacy: Clinical assessments: investigator questionnaire
Physician rated Clinical Global Impression scale (CGI)
Time frame: 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
Time frame: 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
Time frame: At hospital discharge, 6 weeks, 4-, 6-, 12-, 18- and 24-months post-IS
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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