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

Bone grafting procedure with investigated medical device

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

Alexey Y. Drobyshev, MD,PhD,Prof.

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.

Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

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)

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

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.

Evaluation of the Adverse Events and Serious Adverse Events frequency

Evaluation of the events frequency when the surgery was not completed due to the reasons related with gene-activated bone substitute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	NCT03076138	Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss	Gene-activated ...	18 Years - 60 Years	Histograft Co., Ltd.
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	NCT03076138	Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss	Gene-activated ...	18 Years - 60 Years	Histograft Co., Ltd.
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	NCT03076138	Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss	Gene-activated ...	18 Years - 60 Years	Histograft Co., Ltd.

Spots Global Cancer Trial Database for bone deformity