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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Bone tissue formation in the field of gene-activated bone substitute implantation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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, removal of benign neoplasms and pseudotumors, etc.) or alveolar ridge atrophy.
排除标准
- •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 trials (or administration of study products) within 3 months prior the study;
- •conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.);
- •pregnancy or lactation;
- •malignancies including post-treatment period (surgical, chemotherapy, radiation therapy both alone and in different combinations) less than 5 years prior the study.
研究组 & 干预措施
Test group
Bone grafting with gene-activated matrix (OCP + plasmid DNA with VEGF gene)
干预措施: Gene-activated matrix (OCP + plasmid DNA with VEGF gene) (Device)
结局指标
主要结局
Bone tissue formation in the field of gene-activated bone substitute implantation
时间窗: 6 months
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.
次要结局
- Adverse Events and Serious Adverse Events(6 months)
- Surgical failure rate(6 months)