NCT06335394

Prospective Study in Adults Evaluating Safety & Efficacy of NVD003 for Bone Reconstruction to Treat Lower Limb Nonunion

A Prospective Multicentre Single-arm Study in Adults to Evaluate the Safety and Preliminary Efficacy of the Autologous 3D Osteogenic Implant NVD-003 for Bone Reconstruction for the Treatment of Recalcitrant Lower Limb Nonunion

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Novadip Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant NVD-003 for bone reconstruction for the treatment of recalcitrant lower limb nonunion.

Detailed description

This is a first in man study conducted as a prospective, single-arm, non-randomized clinical study. A sample of 5 to 10 patients will be enrolled in the study in order to assess the safety of the use of NVD-003 bone graft implantation in patients with recalcitrant lower limb nonunion. The sample size of 5 to 10 patients was considered sufficient to give a preliminary indication on the safety of the ATMP.

Conditions

• Recalcitrant Lower Limb Nonunion

Interventions

Type	Name	Description
OTHER	NVD003	Autologous osteogenic implant NVD-003 for bone reconstruction

Timeline

• Start date: 2018-08-02
• Primary completion: 2022-04-27
• Completion: 2028-05-15
• First posted: 2024-03-28
• Last updated: 2024-03-28

Locations

10 sites across 3 countries: Belgium, Luxembourg, Switzerland