Safety and Efficacy Study of Traumatic Bone Defects Treatment With Use of 3D Tissue Engineered Equivalent.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Radiographic and MRI assessment in progression
研究概览
简要总结
This study investigates safety and efficacy of traumatic bone defects treatment with use of 3D tissue engineered bone equivalent (3D-TEBE).
The aim of this study is to evaluate 3D-TEBE transplantation as a safe and efficient treatment for patients with traumatic long bone defects of critical size.
详细描述
This new method of critical sized long bone defects treatment is under clinical development. Treatment of critical sized bone defects is an actual clinical challenge. The "gold standard" in this case is autologous bone grafting. The method disadvantage is associated with limited donor bone resources. Based on our preliminary clinical trial positive results on use of autologous cultured bone marrow-derived multipotent mesenchymal stromal cells (BM-MSCs) in traumatology, our aim was to develop 3D tissue-engineered bone equivalent transplantation technology for restoration of critical sized bone defects. The proposed 3D-TEBE transplantation for bone defects of critical size treatment expecting to restore the bone integrity, form new bone tissue in a site of bone defect, and reduce the rehabilitation period of a patient.
The data obtained from this study will have practical implications for the treatment of reparative osteogenesis alterations and will be based on the principles of evidence-based medicine
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
盲法说明
Open
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
- •Age 18 to 60 years
- •Patients with long bone defects of critical size of the traumatic genesis;
- •Lack of consolidation of bone fragments for at least 9 months;
- •At least two attempts to achieve bone consolidation using traditional methods of treatment;
- •A negative pregnancy test at women of childbearing age;
- •Confirmation of participation in the study by signing The Written Informed Consent, personally or through a responsible caretaker;
排除标准
- •The infection in the area of bone defect;
- •History of prior cancer;
- •Diabetes;
- •Severe chronic liver diseases or kidneys disease in history
- •Pregnancy;
- •The presence of vascular, endocrine and somatic pathology which has a direct impact on the osteoreparation;
- •Any other physical diseases in decompensation or subcompensation, or those that are rated as severe or moderate;
- •Therapeutic issues or psychiatric disorders of a patient which would make the subject unsuitable to participate in this study or to complete it;
- •Participation in another clinical trial.
结局指标
主要结局
Radiographic and MRI assessment in progression
时间窗: 12 months +3 years following 3D Tissue Engineered Bone Equivalent grafting
Radiological and MRI progression of consolidation of bone fragments
次要结局
- Reduction of pain using VAS(6 months)
- Cost analysis based on length of hospital stay(6 months)