Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery

Alveolar Bone Atrophy Clinical Trial

Official title:

Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02293031
• Other study ID #: RU-NextGen-20-01-2013
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 11, 2014
• Last updated: March 5, 2017
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2016
• Source: NextGen Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate safety and efficacy of gene-activated matrix ("Nucleostim") for regeneration of bone tissue in maxillofacial area. Patients with congenital and acquired maxillofacial defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy will be included into the study.

Description:

All patients enrolled into the study will receive standard surgery procedures indicated in accordance with medical care standards for the certain disease. Maxillofacial bone defects (formed after injuries, surgeries, excision of benign neoplasms and pseudotumors, teeth extraction, etc.) or areas of alveolar bone atrophy will be the filled by gene-activated matrix "Nucleostim". Safety and efficacy of implanted osteoplastic material will be assessed by physical examination, comprehensive laboratory tests, X-ray examination within 60 days after operation.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 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, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone 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 studies (or administration of study products) within 3 months prior the study;

• conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.);

• malignancies including post-surgical period with chemo- and (or) radiation therapy);

• vascular malformations;

• pregnancy or lactation.

Related Conditions & MeSH terms

• Alveolar Bone Atrophy
• Alveolar Bone Loss
• Atrophy
• Bone Neoplasm, Benign
• Bone Neoplasms
• Disorders of Teeth and Jaw
• Jaw Fractures
• Maxillofacial Bone Defects
• Maxillofacial Bone Deformities
• Neoplasms
• Tooth Diseases

Intervention

Device:
• Gene-activated matrix "Nucleostim"
Gene-activated matrix "Nucleostim" is bone graft substitute consisting of collagen-hydroxyapatite composite scaffold and DNA plasmids with gene encoding vascular endothelial grothw factor (VEGF-A165) in concentration 100-120 ng/mg which is an active substance of gene-therapeutic drug "Neovasculgen"®.

Locations

Country	Name	City	State
Russian Federation	Burnasyan Federal Medical Biophysical Center	Moscow
Russian Federation	Moscow State University of Medicine and Dentistry	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
NextGen Company Limited	Burnasyan Federal Medical Biophysical Center, Moscow State University of Medicine and Dentistry

Country where clinical trial is conducted

Russian Federation, 

References & Publications (4)

Bozo I.Y., Deev R.V., Drobyshev A.Y., D. Galetskiy D.V., Isaev A.A. Gene technologies in maxillofacial surgery: development of gene-activated bone grafts. International Journal of Oral and Maxillofacial Surgery 42(10): 1179-1180, 2013

Bozo IY, Deev RV, Drobyshev AY, Isaev AA, Eremin II. World's First Clinical Case of Gene-Activated Bone Substitute Application. Case Rep Dent. 2016;2016:8648949. — View Citation

Deev R.V., Drobyshev A.Y., Bozo I.Y., Isaev A.A. Angiogenic non-viral gene transfer: from ischemia treatment to bone defects repair. J Tissue Eng. Regen. Med. 8 (Suppl. 1): 64-65, 2014

Deev RV, Bozo IIa, Mzhavanadze ND, Nersesian EG, Chukhralia OV, Shval'b PG, Cherviakov IuV, Staroverov IN, Kalinin RE, Voronov DA, Gavrilenko AV, Isaev AA. [Efficacy of using VEGF165 gene in comprehensive treatment of patients with stage 2A-3 lower limb chronic ischaemia]. Angiol Sosud Khir. 2014;20(2):38-48. Russian. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation	To determine the quantity of newly-formed bone tissue the morphometric parameters of regenerate will be measured on CT scan using special tools ("ROI", region of interest, etc.); The morphometric parameters of bone regenerate include: average density (in HU); size (length, width, height) and volume.	60 days
Secondary	Pain scores on the visual analog scale		60 days
Secondary	Surgical failure rate		60 days
Secondary	Adverse Events		60 days
Secondary	Edema scores on the 0-10 Numeric Rating Scale	Level of edema at the surgical site will be assessed by physician using 0-10 Numeric Rating Scale.	60