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)

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.

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.