Clinical trial · Interventional
Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery
Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration
NCT02293031CI-TRIAL-00026314unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alveolar Bone Atrophy | — | UNRESOLVED | — |
| Bone Neoplasm, Benign | Benign Bone Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Disorders of Teeth and Jaw | — | UNRESOLVED | — |
| Jaw Fractures | — | UNRESOLVED | — |
| Maxillofacial Bone Defects | — | UNRESOLVED | — |
| Maxillofacial Bone Deformities | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gene-activated matrix "Nucleostim" | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gene-activated matrix "Nucleostim"
- description
- Implantation of gene-activated matrix "Nucleostim" into the bone defects or sites of bone atrophy
- interventionNames
- Device: Gene-activated matrix "Nucleostim"
Primary outcomes (1)
- measure
- Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation
- timeFrame
- 60 days
- description
- 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.
Secondary outcomes (4)
- measure
- Pain scores on the visual analog scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDBozo 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
- BACKGROUNDDeev 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
- BACKGROUNDDeev 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. PMID 24961325
- RESULTBozo 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. PMID 27891264