NCT05961956

Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis

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.

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Novadip Biosciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	NVDX3	NVDX3 is implanted during a single surgical intervention.

Timeline

• Start date: 2023-10-12
• Primary completion: 2026-04-18
• Completion: 2026-04-18
• First posted: 2023-07-27
• Last updated: 2025-12-24

Locations

1 site across 1 country: Luxembourg