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Brief Title: Gene-activated Bone Substitute for Maxillofacial Bone Regeneration
Official Title: 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)
Study ID: NCT03076138
Brief Summary: 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: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
A.I. Moscow State University of Medicine and Dentistry, Moscow, , Russian Federation
Name: Alexey Y. Drobyshev, MD,PhD,Prof.
Affiliation: A.I. Evdokimov Moscow State University of Medicine and Dentistry
Role: PRINCIPAL_INVESTIGATOR