Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery

NextGen Company

Status: Unknown

Conditions: Bone Neoplasm, Benign; Disorders of Teeth and Jaw; Jaw Fractures; Maxillofacial Bone Defects; Maxillofacial Bone Deformities; Alveolar Bone Atrophy

Treatments: Device: Gene-activated matrix "Nucleostim"

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02293031

RU-NextGen-20-01-2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Gene-activated matrix "Nucleostim"

Experimental group

Description:

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

Treatment:

Device: Gene-activated matrix "Nucleostim"