Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

NCT03076138 | Completed

• 1 other identifier: RU-Histograft-20-08-2016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Cysts; Bone Atrophy; Bone Deformity; Bone Fracture; Bone Loss; Tooth Loss

Keywords

Gene-activated matrix; Bone substitute; Bone grafting; Dental implantation; gene therapy; plasmid DNA; VEGF gene; octacalcium phosphate

Outcome Measures

Primary Outcomes (1)

• Bone tissue formation in the field of gene-activated bone substitute implantation

  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.

  6 months

Secondary Outcomes (2)

• Adverse Events and Serious Adverse Events

  6 months

• Surgical failure rate

  6 months

Study Arms (1)

Test group

EXPERIMENTAL

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

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

Interventions

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

Bone grafting procedure with investigated medical device

Test group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Histograft Co., Ltd.: lead
• Moscow State University of Medicine and Dentistry: collaborator

Study Sites (1)

A.I. Moscow State University of Medicine and Dentistry

Moscow, 127473, Russia

Location

Related Publications (5)

• Deev RV, Drobyshev AY, Bozo IY, Isaev AA. Ordinary and Activated Bone Grafts: Applied Classification and the Main Features. Biomed Res Int. 2015;2015:365050. doi: 10.1155/2015/365050. Epub 2015 Nov 15.

  PMID: 26649300 BACKGROUND

• Komlev VS, Barinov SM, Bozo II, Deev RV, Eremin II, Fedotov AY, Gurin AN, Khromova NV, Kopnin PB, Kuvshinova EA, Mamonov VE, Rybko VA, Sergeeva NS, Teterina AY, Zorin VL. Bioceramics composed of octacalcium phosphate demonstrate enhanced biological behavior. ACS Appl Mater Interfaces. 2014 Oct 8;6(19):16610-20. doi: 10.1021/am502583p. Epub 2014 Sep 16.

  PMID: 25184694 BACKGROUND

• Komlev VS, Popov VK, Mironov AV, Fedotov AY, Teterina AY, Smirnov IV, Bozo IY, Rybko VA, Deev RV. 3D Printing of Octacalcium Phosphate Bone Substitutes. Front Bioeng Biotechnol. 2015 Jun 8;3:81. doi: 10.3389/fbioe.2015.00081. eCollection 2015.

  PMID: 26106596 BACKGROUND

• Deev R, Plaksa I, Bozo I, Isaev A. Results of an International Postmarketing Surveillance Study of pl-VEGF165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease. Am J Cardiovasc Drugs. 2017 Jun;17(3):235-242. doi: 10.1007/s40256-016-0210-3.

  PMID: 28050885 BACKGROUND

• Deev RV, Bozo IY, Mzhavanadze ND, Voronov DA, Gavrilenko AV, Chervyakov YV, Staroverov IN, Kalinin RE, Shvalb PG, Isaev AA. pCMV-vegf165 Intramuscular Gene Transfer is an Effective Method of Treatment for Patients With Chronic Lower Limb Ischemia. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):473-82. doi: 10.1177/1074248415574336. Epub 2015 Mar 13.

  PMID: 25770117 BACKGROUND

MeSH Terms

Conditions

Bone Cysts; Fractures, Bone; Bone Diseases, Metabolic; Tooth Loss

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Metabolic Diseases; Nutritional and Metabolic Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Alexey Y. Drobyshev, MD,PhD,Prof.

  A.I. Evdokimov Moscow State University of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: March 10, 2017
• Study Start: March 6, 2017
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)