Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery

March 5, 2017 updated by: NextGen Company Limited

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Moscow State University of Medicine and Dentistry
      • Moscow, Russian Federation
        • Burnasyan Federal Medical Biophysical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • obtained voluntary informed consent for participation in the clinical study;
  • congenital and acquired maxillofacial bone defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy.

Exclusion Criteria:

  • not able or unwilling to give voluntary informed consent for the study or follow requirements of the clinical study;
  • decompensated chronic visceral diseases;
  • clinically significant laboratory abnormalities;
  • HIV, HBV and HCV antibodies in serum;
  • alcohol consumption within 4 days prior the study;
  • history of drug addiction;
  • participation in other clinical studies (or administration of study products) within 3 months prior the study;
  • conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.);
  • malignancies including post-surgical period with chemo- and (or) radiation therapy);
  • vascular malformations;
  • pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gene-activated matrix "Nucleostim"
Implantation of gene-activated matrix "Nucleostim" into the bone defects or sites of bone atrophy
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"®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation
Time Frame: 60 days

To determine the quantity of newly-formed bone tissue the morphometric parameters of regenerate will be measured on CT scan using special tools ("ROI", region of interest, etc.)

The morphometric parameters of bone regenerate include:

  • average density (in HU);
  • size (length, width, height) and volume.
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores on the visual analog scale
Time Frame: 60 days
60 days
Surgical failure rate
Time Frame: 60 days
60 days
Adverse Events
Time Frame: 60 days
60 days
Edema scores on the 0-10 Numeric Rating Scale
Time Frame: 60
Level of edema at the surgical site will be assessed by physician using 0-10 Numeric Rating Scale.
60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NextGen Company Limited

Collaborators

Moscow State University of Medicine and Dentistry
Burnasyan Federal Medical Biophysical Center

Investigators

  • Principal Investigator: Alexey Yu Drobyshev, MD, PhD, DSc, Moscow State University of Medicine and Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 11, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 5, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RU-NextGen-20-01-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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