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Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

Primary Purpose

Bone Cysts, Bone Atrophy, Bone Deformity

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Gene-activated matrix (OCP + plasmid DNA with VEGF gene)
Sponsored by
Histograft Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Cysts focused on measuring Gene-activated matrix, Bone substitute, Bone grafting, Dental implantation, gene therapy, plasmid DNA, VEGF gene, octacalcium phosphate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test group

Arm Description

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

Outcomes

Primary Outcome Measures

Bone tissue formation in the field of gene-activated bone substitute implantation
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.

Secondary Outcome Measures

Adverse Events and Serious Adverse Events
Evaluation of the Adverse Events and Serious Adverse Events frequency
Surgical failure rate
Evaluation of the events frequency when the surgery was not completed due to the reasons related with gene-activated bone substitute

Full Information

First Posted
March 5, 2017
Last Updated
May 5, 2019
Sponsor
Histograft Co., Ltd.
Collaborators
Moscow State University of Medicine and Dentistry
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1. Study Identification

Unique Protocol Identification Number
NCT03076138
Brief Title
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
December 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Histograft Co., Ltd.
Collaborators
Moscow State University of Medicine and Dentistry

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Cysts, Bone Atrophy, Bone Deformity, Bone Fracture, Bone Loss, Tooth Loss
Keywords
Gene-activated matrix, Bone substitute, Bone grafting, Dental implantation, gene therapy, plasmid DNA, VEGF gene, octacalcium phosphate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
Bone grafting with gene-activated matrix (OCP + plasmid DNA with VEGF gene)
Intervention Type
Device
Intervention Name(s)
Gene-activated matrix (OCP + plasmid DNA with VEGF gene)
Intervention Description
Bone grafting procedure with investigated medical device
Primary Outcome Measure Information:
Title
Bone tissue formation in the field of gene-activated bone substitute implantation
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adverse Events and Serious Adverse Events
Description
Evaluation of the Adverse Events and Serious Adverse Events frequency
Time Frame
6 months
Title
Surgical failure rate
Description
Evaluation of the events frequency when the surgery was not completed due to the reasons related with gene-activated bone substitute
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexey Y. Drobyshev, MD,PhD,Prof.
Organizational Affiliation
A.I. Evdokimov Moscow State University of Medicine and Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.I. Moscow State University of Medicine and Dentistry
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Detailed results of the study will be published in a specialized peer-reviewed scientific journal with an open access
Citations:
PubMed Identifier
26649300
Citation
Deev RV, Drobyshev AY, Bozo IY, Isaev AA. Ordinary and Activated Bone Grafts: Applied Classification and the Main Features. Biomed Res Int. 2015;2015:365050. doi: 10.1155/2015/365050. Epub 2015 Nov 15.
Results Reference
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PubMed Identifier
25184694
Citation
Komlev VS, Barinov SM, Bozo II, Deev RV, Eremin II, Fedotov AY, Gurin AN, Khromova NV, Kopnin PB, Kuvshinova EA, Mamonov VE, Rybko VA, Sergeeva NS, Teterina AY, Zorin VL. Bioceramics composed of octacalcium phosphate demonstrate enhanced biological behavior. ACS Appl Mater Interfaces. 2014 Oct 8;6(19):16610-20. doi: 10.1021/am502583p. Epub 2014 Sep 16.
Results Reference
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PubMed Identifier
26106596
Citation
Komlev VS, Popov VK, Mironov AV, Fedotov AY, Teterina AY, Smirnov IV, Bozo IY, Rybko VA, Deev RV. 3D Printing of Octacalcium Phosphate Bone Substitutes. Front Bioeng Biotechnol. 2015 Jun 8;3:81. doi: 10.3389/fbioe.2015.00081. eCollection 2015.
Results Reference
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PubMed Identifier
28050885
Citation
Deev R, Plaksa I, Bozo I, Isaev A. Results of an International Postmarketing Surveillance Study of pl-VEGF165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease. Am J Cardiovasc Drugs. 2017 Jun;17(3):235-242. doi: 10.1007/s40256-016-0210-3.
Results Reference
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PubMed Identifier
25770117
Citation
Deev RV, Bozo IY, Mzhavanadze ND, Voronov DA, Gavrilenko AV, Chervyakov YV, Staroverov IN, Kalinin RE, Shvalb PG, Isaev AA. pCMV-vegf165 Intramuscular Gene Transfer is an Effective Method of Treatment for Patients With Chronic Lower Limb Ischemia. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):473-82. doi: 10.1177/1074248415574336. Epub 2015 Mar 13.
Results Reference
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Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

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