NCT05693558

NVD-003 in the Treatment of Congenital Pseudarthrosis of the Tibia

A Proof-of-concept Study With NVD-003, an Autologous Osteogenic Bone Graft, in the Treatment of Congenital Pseudarthrosis of the Tibia in Pediatric Patients.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (estimated)
• Sponsor: Novadip Biosciences · Industry
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

A single arm, multi-country, multi-center study in pediatric patients, suffering from congenital pseudarthrosis of the tibia (CPT), treated during the primary surgical intervention with NVD-003, an autologous 3D scaffold free osteogenic graft.

Detailed description

Congenital pseudarthrosis is a rare disorder of unknown aetiology and variable history that manifests itself as a non-union or pseudarthrosis of fractures that develop spontaneously or following minor trauma. It can be defined as a disorder of the diaphysis which is revealed by either pseudarthrosis at birth or by a pathological fracture presenting in bone with modifications such as bowing, narrowing of the medullary canal or a cyst. Although uncommon, CPT is the most frequently observed type of congenital pseudarthrosis. Its incidence is reported to be between 1:140,000 to 1:250,000 live births. Autologous bone grafting is considered the gold standard approach as this material vascularizes and integrates with surrounding bone, minimizing the risk of infection, dislodgement, or break-down. NVD-003 is a scaffold free 3D osteogenic graft derived from autologous adipose stem cells which become embedded in their extracellular matrix and combined with hydroxyapatite/beta-tricalcium phosphate (HA/βTCP) particles. NVD-003 is intended to promote bone formation, supporting the physiological bone healing process in severe pathophysiological conditions such as hypoxia, lack of mineralized callus formation, bone resorption and low osteogenicity.

Conditions

• Congenital Pseudarthrosis of Tibia

Interventions

Type	Name	Description
BIOLOGICAL	NVD-003, an autologous 3D scaffold free osteogenic graft	Bone correction and grafting surgery

Timeline

• Start date: 2022-11-24
• Primary completion: 2025-01-01
• Completion: 2026-01-01
• First posted: 2023-01-23
• Last updated: 2024-01-26

Locations

2 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated drug study