Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Bone Cysts, Bone Atrophy, Bone Deformity, Bone Fracture, Bone Loss, Tooth Loss

Intervention / Treatment
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* Device: Gene-activated matrix (OCP + plasmid DNA with VEGF gene)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Bone grafting with gene-activated matrix (OCP + plasmid DNA with VEGF gene) | Device: Gene-activated matrix (OCP + plasmid DNA with VEGF gene)<br>* Bone grafting procedure with investigated medical device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gene-activated matrix, Bone substitute, Bone grafting, Dental implantation, gene therapy, plasmid DNA, VEGF gene, octacalcium phosphate