Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis

NCT05961956 | Active Not Recruiting Phase 1

• 2 other identifiers: NVDX3-CLN022022-002771-11
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Lumbar Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• Primary Safety Endpoint

  Description of all SAEs and NVDX3 related AEs

  Up to 24 months post implant surgery

Secondary Outcomes (14)

• Safety: all acute SAEs and NVDX3 related AEs

  Between screening (V1) and 6 weeks post-IS (V4)

• Safety: all SAEs and NVDX3 related AEs

  Beyond 6 weeks (V4 excluded) until 12 months post-IS

• Safety: all SAEs and NVDX3 related AEs

  Beyond 12 months (V7 excluded) until 24 months post-IS

• Safety: TEAEs

  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

  Between screening (v1) till 24 months post-IS

Study Arms (1)

NVDX3 osteogenic implant

EXPERIMENTAL

Drug: NVDX3

Interventions

NVDX3 DRUG

NVDX3 is implanted during a single surgical intervention.

NVDX3 osteogenic implant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Novadip Biosciences: lead

Study Sites (1)

Centre Hospitalier de Luxembourg

Luxembourg, 1210, Luxembourg

Location

Study Officials

• David BREUSKIN, MD

  Centre Hospitalier du Luxembourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 27, 2023
• Study Start: October 12, 2023
• Primary Completion: April 18, 2026
• Study Completion: April 18, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

LU (1)