Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

May 5, 2019 updated by: Histograft Co., Ltd.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

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, 127473
        • A.I. Moscow State University of Medicine and Dentistry

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 60 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, removal of benign neoplasms and pseudotumors, etc.) or alveolar ridge 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 trials (or administration of study products) within 3 months prior the study;
  • conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.);
  • pregnancy or lactation;
  • malignancies including post-treatment period (surgical, chemotherapy, radiation therapy both alone and in different combinations) less than 5 years prior the study.

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: Test group
Bone grafting with gene-activated matrix (OCP + plasmid DNA with VEGF gene)
Device: Gene-activated matrix (OCP + plasmid DNA with VEGF gene)
Bone grafting procedure with investigated medical device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone tissue formation in the field of gene-activated bone substitute implantation
Time Frame: 6 months

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

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

All together both measurements allow to determine "bone tissue formation" as a value derived from the presence of newly formed bone tissue and its volume correspondence with the quantity of the material implanted.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events and Serious Adverse Events
Time Frame: 6 months
Evaluation of the Adverse Events and Serious Adverse Events frequency
6 months
Surgical failure rate
Time Frame: 6 months
Evaluation of the events frequency when the surgery was not completed due to the reasons related with gene-activated bone substitute
6 months

Collaborators and Investigators

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

Sponsor

Histograft Co., Ltd.

Collaborators

Moscow State University of Medicine and Dentistry

Investigators

  • Principal Investigator: Alexey Y. Drobyshev, MD,PhD,Prof., A.I. Evdokimov 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 (Actual)

March 6, 2017

Primary Completion (Actual)

December 14, 2018

Study Completion (Actual)

December 14, 2018

Study Registration Dates

First Submitted

March 5, 2017

First Submitted That Met QC Criteria

March 5, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 5, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RU-Histograft-20-08-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Detailed results of the study will be published in a specialized peer-reviewed scientific journal with an open access

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Bone Loss

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe