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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05693558
Study type Interventional
Source Novadip Biosciences
Contact
Status Active, not recruiting
Phase Phase 1
Start date November 24, 2022
Completion date January 2026

See also
  Status Clinical Trial Phase
Recruiting NCT02896114 - A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China
Terminated NCT02718131 - A Study of INFUSE Bone Graft (BMP-2) in the Treatment of Tibial Pseudarthrosis in Neurofibromatosis Type 1 (NF1) N/A
Recruiting NCT02640040 - The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia N/A
Recruiting NCT03257826 - The Effect of Percutaneous Kirschner Wire Technique in Management of CPT Under One Year Old N/A