Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

Bone Loss Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076138
• Other study ID #: RU-Histograft-20-08-2016
• Status: Completed
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: December 14, 2018

Study information

• Verified date: May 2019
• Source: Histograft Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 14, 2018
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Bone Atrophy
• Bone Cysts
• Bone Deformity
• Bone Fracture
• Bone Loss
• Fractures, Bone
• Tooth Loss

Intervention

Device:
• Gene-activated matrix (OCP + plasmid DNA with VEGF gene)
Bone grafting procedure with investigated medical device

Locations

Country	Name	City	State
Russian Federation	A.I. Moscow State University of Medicine and Dentistry	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Histograft Co., Ltd.	Moscow State University of Medicine and Dentistry

Country where clinical trial is conducted

Russian Federation, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse Events and Serious Adverse Events	Evaluation of the Adverse Events and Serious Adverse Events frequency	6 months
Secondary	Surgical failure rate	Evaluation of the events frequency when the surgery was not completed due to the reasons related with gene-activated bone substitute	6 months