Symptoms and General Pathology

All Conditions

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Musculoskeletal Diseases

Mouth and Tooth Diseases

Neoplasms

Nervous System Diseases

Atrophy

Congenital Abnormalities

Fractures, Bone

Alveolar Bone Loss

Bone Neoplasms

Tooth Diseases

Jaw Fractures

Pathological Conditions, Anatomical

Bone Diseases

Bone Resorption

Periodontal Atrophy

Periodontal Diseases

Mouth Diseases

Stomatognathic Diseases

Maxillofacial Injuries

Facies

Facial Injuries

Craniocerebral Trauma

Trauma, Nervous System

Skull Fractures

Implantation of gene-activated matrix "Nucleostim" into the bone defects or sites of bone atrophy

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"®.

Gene-activated matrix "Nucleostim"

Alexey Yu Drobyshev, MD, PhD, DSc

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.

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

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.

Level of edema at the surgical site will be assessed by physician using 0-10 Numeric Rating Scale.

Burnasyan Federal Medical Biophysical Center

Moscow State University of Medicine and Dentistry

NextGen Company Limited

Cysts

Bone Cysts

Tooth Loss

Bone grafting with gene-activated matrix (OCP + plasmid DNA with VEGF gene)

Bone grafting procedure with investigated medical device

Gene-activated matrix (OCP + plasmid DNA with VEGF gene)

Alexey Y. Drobyshev, MD,PhD,Prof.

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.

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.

Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

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)

Detailed results of the study will be published in a specialized peer-reviewed scientific journal with an open access

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.

Evaluation of the Adverse Events and Serious Adverse Events frequency

Evaluation of the events frequency when the surgery was not completed due to the reasons related with gene-activated bone substitute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery	NCT02293031	Maxillofacial B... Alveolar Bone A... Jaw Fractures Maxillofacial B... Bone Neoplasm, ... Disorders of Te...	Gene-activated ...	18 Years - 55 Years	NextGen Company Limited
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	NCT03076138	Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss	Gene-activated ...	18 Years - 60 Years	Histograft Co., Ltd.
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	NCT03076138	Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss	Gene-activated ...	18 Years - 60 Years	Histograft Co., Ltd.
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	NCT03076138	Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss	Gene-activated ...	18 Years - 60 Years	Histograft Co., Ltd.

Spots Global Cancer Trial Database for vegf gene

Every month we try and update this database with for vegf gene cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vegf gene

Every month we try and update this database with for vegf gene cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vegf gene cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.