Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

Histograft Co., Ltd.20 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss

Interventions

Gene-activated matrix (OCP + plasmid DNA with VEGF gene)DEVICE

Bone grafting procedure with investigated medical device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

A.I. Moscow State University of Medicine and Dentistry

Moscow, Russia

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Adverse Events and Serious Adverse Events

Evaluation of the Adverse Events and Serious Adverse Events frequency

Time frame: 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

Time frame: 6 months

Data from ClinicalTrials.gov

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