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Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

NCT03076138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-05-07

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Gene-activated matrix (OCP + plasmid DNA with VEGF gene)

Bone grafting procedure with investigated medical device

Sponsors & Collaborators

  • Moscow State University of Medicine and Dentistry

    collaborator OTHER

  • Histograft Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Alexey Y. Drobyshev, MD,PhD,Prof. · A.I. Evdokimov 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
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2018-12-14
Completion
2018-12-14

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 NCT03076138 on ClinicalTrials.gov