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Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery

NCT02293031 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-03-07

No results posted yet for this study

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.

Conditions

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

Interventions

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"®.

Sponsors & Collaborators

  • Burnasyan Federal Medical Biophysical Center

    collaborator OTHER_GOV

  • Moscow State University of Medicine and Dentistry

    collaborator OTHER

  • NextGen Company Limited

    lead INDUSTRY

Principal Investigators

  • Alexey Yu Drobyshev, MD, PhD, DSc · Moscow State University of Medicine and Dentistry

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-08-31
Completion
2017-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293031 on ClinicalTrials.gov