Clinical trial NCT02293031: Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery
Official title: Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillofacial Bone Defects
Alveolar Bone Atrophy
Jaw Fractures
Maxillofacial Bone Deformities
Bone Neoplasm, Benign
Disorders of Teeth and Jaw
Keywords: maxillofacial bone defects
alveolar ridge atrophy
gene-activated matrix
VEGF gene
DNA plasmid
bone gene therapy
Lead sponsor: NextGen Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Burnasyan Federal Medical Biophysical Center
name: Moscow State University of Medicine and Dentistry
First posted: 2014-11-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation
timeFrame: 60 days
Secondary outcomes:
measure: Pain scores on the visual analog scale
timeFrame: 60 days
measure: Surgical failure rate
timeFrame: 60 days
measure: Adverse Events
timeFrame: 60 days
measure: Edema scores on the 0-10 Numeric Rating Scale
timeFrame: 60
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Burnasyan Federal Medical Biophysical Center
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry
Study officials:
affiliation: Moscow State University of Medicine and Dentistry
name: Alexey Yu Drobyshev, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
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
citation: 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.
citation: 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. doi: 10.1155/2016/8648949. Epub 2016 Nov 7.