Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery
Primary Purpose
Maxillofacial Bone Defects, Alveolar Bone Atrophy, Jaw Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Gene-activated matrix "Nucleostim"
Sponsored by
About this trial
This is an interventional treatment trial for Maxillofacial Bone Defects focused on measuring maxillofacial bone defects, alveolar ridge atrophy, gene-activated matrix, VEGF gene, DNA plasmid, bone gene therapy
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, 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.
Sites / Locations
- Burnasyan Federal Medical Biophysical Center
- Moscow State University of Medicine and Dentistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gene-activated matrix "Nucleostim"
Arm Description
Implantation of gene-activated matrix "Nucleostim" into the bone defects or sites of bone atrophy
Outcomes
Primary Outcome Measures
Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation
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.
Secondary Outcome Measures
Pain scores on the visual analog scale
Surgical failure rate
Adverse Events
Edema scores on the 0-10 Numeric Rating Scale
Level of edema at the surgical site will be assessed by physician using 0-10 Numeric Rating Scale.
Full Information
NCT ID
NCT02293031
First Posted
November 11, 2014
Last Updated
March 5, 2017
Sponsor
NextGen Company Limited
Collaborators
Burnasyan Federal Medical Biophysical Center, Moscow State University of Medicine and Dentistry
1. Study Identification
Unique Protocol Identification Number
NCT02293031
Brief Title
Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery
Official Title
Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NextGen Company Limited
Collaborators
Burnasyan Federal Medical Biophysical Center, Moscow State University of Medicine and Dentistry
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillofacial Bone Defects, Alveolar Bone Atrophy, Jaw Fractures, Maxillofacial Bone Deformities, Bone Neoplasm, Benign, Disorders of Teeth and Jaw
Keywords
maxillofacial bone defects, alveolar ridge atrophy, gene-activated matrix, VEGF gene, DNA plasmid, bone gene therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gene-activated matrix "Nucleostim"
Arm Type
Experimental
Arm Description
Implantation of gene-activated matrix "Nucleostim" into the bone defects or sites of bone atrophy
Intervention Type
Device
Intervention Name(s)
Gene-activated matrix "Nucleostim"
Intervention Description
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"®.
Primary Outcome Measure Information:
Title
Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation
Description
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.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Pain scores on the visual analog scale
Time Frame
60 days
Title
Surgical failure rate
Time Frame
60 days
Title
Adverse Events
Time Frame
60 days
Title
Edema scores on the 0-10 Numeric Rating Scale
Description
Level of edema at the surgical site will be assessed by physician using 0-10 Numeric Rating Scale.
Time Frame
60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 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, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexey Yu Drobyshev, MD, PhD, DSc
Organizational Affiliation
Moscow State University of Medicine and Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burnasyan Federal Medical Biophysical Center
City
Moscow
Country
Russian Federation
Facility Name
Moscow State University of Medicine and Dentistry
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Citations:
Citation
Bozo I.Y., Deev R.V., Drobyshev A.Y., D. Galetskiy D.V., Isaev A.A. Gene technologies in maxillofacial surgery: development of gene-activated bone grafts. International Journal of Oral and Maxillofacial Surgery 42(10): 1179-1180, 2013
Results Reference
background
Citation
Deev R.V., Drobyshev A.Y., Bozo I.Y., Isaev A.A. Angiogenic non-viral gene transfer: from ischemia treatment to bone defects repair. J Tissue Eng. Regen. Med. 8 (Suppl. 1): 64-65, 2014
Results Reference
background
PubMed Identifier
24961325
Citation
Deev RV, Bozo IIa, Mzhavanadze ND, Nersesian EG, Chukhralia OV, Shval'b PG, Cherviakov IuV, Staroverov IN, Kalinin RE, Voronov DA, Gavrilenko AV, Isaev AA. [Efficacy of using VEGF165 gene in comprehensive treatment of patients with stage 2A-3 lower limb chronic ischaemia]. Angiol Sosud Khir. 2014;20(2):38-48. Russian.
Results Reference
background
PubMed Identifier
27891264
Citation
Bozo IY, Deev RV, Drobyshev AY, Isaev AA, Eremin II. World's First Clinical Case of Gene-Activated Bone Substitute Application. Case Rep Dent. 2016;2016:8648949. doi: 10.1155/2016/8648949. Epub 2016 Nov 7.
Results Reference
result
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Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery
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