NCT02293031

Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery

Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: NextGen Company Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety and efficacy of gene-activated matrix ("Nucleostim") for regeneration of bone tissue in maxillofacial area. Patients with congenital and acquired maxillofacial defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy will be included into the study.

Detailed description

All patients enrolled into the study will receive standard surgery procedures indicated in accordance with medical care standards for the certain disease. Maxillofacial bone defects (formed after injuries, surgeries, excision of benign neoplasms and pseudotumors, teeth extraction, etc.) or areas of alveolar bone atrophy will be the filled by gene-activated matrix "Nucleostim". Safety and efficacy of implanted osteoplastic material will be assessed by physical examination, comprehensive laboratory tests, X-ray examination within 60 days after operation.

Conditions

• Maxillofacial Bone Defects
• Alveolar Bone Atrophy
• Jaw Fractures
• Maxillofacial Bone Deformities
• Bone Neoplasm, Benign
• Disorders of Teeth and Jaw

Interventions

Type	Name	Description
DEVICE	Gene-activated matrix "Nucleostim"	Gene-activated matrix "Nucleostim" is bone graft substitute consisting of collagen-hydroxyapatite composite scaffold and DNA plasmids with gene encoding vascular endothelial grothw factor (VEGF-A165) in concentration 100-120 ng/mg which is an active substance of gene-therapeutic drug "Neovasculgen"®.

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-08-01
• Completion: 2017-12-01
• First posted: 2014-11-18
• Last updated: 2017-03-07

Locations

2 sites across 1 country: Russia