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| Name | Class |
|---|---|
| Burnasyan Federal Medical Biophysical Center | OTHER_GOV |
| Moscow State University of Medicine and Dentistry | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gene-activated matrix "Nucleostim" | Experimental | Implantation of gene-activated matrix "Nucleostim" into the bone defects or sites of bone atrophy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gene-activated matrix "Nucleostim" | Device | 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"®. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores on the visual analog scale | 60 days | |
| Surgical failure rate | 60 days | |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexey Yu Drobyshev, MD, PhD, DSc | Moscow State University of Medicine and Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burnasyan Federal Medical Biophysical Center | Moscow | Russia | ||||
| Moscow State University of Medicine and Dentistry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | 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 | ||
| 24961325 | Background | 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. | |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| D007572 | Jaw Fractures |
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| 60 days |
| 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 |
| Moscow |
| Russia |
| Result |
| 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. |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |