NCT03076138

Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

The Clinical Trial of the Safety and Efficacy of the Medical Device "Bone Substitute Based on Octacalcium Phosphate and Biologically Active Nucleic Acids for Bone Tissue Regeneration" (Nucleostim-VEGF)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Histograft Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of the gene-activated bone substitute consisting of octacalcium phosphate and plasmid DNA encoding vascular endothelial growth factor (VEGF) for maxillofacial bone regeneration. The patients with congenital and acquired maxillofacial bone defects and alveolar ridge atrophy will be enrolled.

Detailed description

All participants of the study will receive standard treatment according to the medical care standards for diseases and pathological conditions characterized by maxillofacial bone defects and/or alveolar ridge atrophy. Bone grafting procedures as part of the surgical treatment will be performed with the use of investigated medical device. The safety and efficacy of the implanted gene-activated bone substitute will be evaluated by clinical examination, comprehensive laboratory tests, and computer tomography within 6 months after surgery.

Conditions

• Bone Cysts
• Bone Atrophy
• Bone Deformity
• Bone Fracture
• Bone Loss
• Tooth Loss

Interventions

Type	Name	Description
DEVICE	Gene-activated matrix (OCP + plasmid DNA with VEGF gene)	Bone grafting procedure with investigated medical device

Timeline

• Start date: 2017-03-06
• Primary completion: 2018-12-14
• Completion: 2018-12-14
• First posted: 2017-03-10
• Last updated: 2019-05-07

Locations

1 site across 1 country: Russia