Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

Histograft

Status

Completed

Conditions

Bone Cysts

Tooth Loss

Bone Atrophy

Bone Fracture

Bone Loss

Bone Deformity

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03076138

RU-Histograft-20-08-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.