Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

Not Applicable

Completed

• Conditions: Bone Atrophy; Bone Fracture; Tooth Loss; Bone Cysts; Bone Deformity; Bone Loss
• Interventions: Device: Gene-activated matrix (OCP + plasmid DNA with VEGF gene)

• Registration Number: NCT03076138
• Lead Sponsor: Histograft Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2017-03-05
• Study First Submitted QC: 2017-03-05
• Study Start: 2017-03-06
• Study First Posted: 2017-03-10
• Primary Completion: 2018-12-14
• Study Completion: 2018-12-14
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-05
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test group	Gene-activated matrix (OCP + plasmid DNA with VEGF gene)	Bone grafting with gene-activated matrix (OCP + plasmid DNA with VEGF gene)

Primary Outcome Measures

Name	Time	Method
Bone tissue formation in the field of gene-activated bone substitute implantation	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events and Serious Adverse Events	6 months	Evaluation of the Adverse Events and Serious Adverse Events frequency
Surgical failure rate	6 months	Evaluation of the events frequency when the surgery was not completed due to the reasons related with gene-activated bone substitute

Trial Locations

Locations (1)

A.I. Moscow State University of Medicine and Dentistry; 🇷🇺 Moscow, Russian Federation