The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The scores of bone healing
研究概览
简要总结
The purpose of this study is to compare use of a tissue-engineered bone to use of a standard allograft bone to treat bone defect in patients. The hypothesis is that use of the tissue-engineered bone is effective and safe to treat the bone defect in patients.
详细描述
Patients with the bone defect without infection and sever system diseases will be recruited.
The material selected as the scaffold for this study will be a porous β-tricalcium phosphate scaffold (β-TCP) scaffold and scaffold is custom-made according to the size and shape of bone defect after three-dimensional CT scan. Human BMSCs will be obtained and cultured before operation and 3.4×106 cells in 10ml serum-free medium will be seeded onto scaffold to construct the tissue engineered bone graft and co-cultured for two weeks.
The implant operation will be carried out under the general anesthesia. The tissue engineered bone graft will be implanted into the bone defect area. The bone defect area will be covered with surrounding soft tissue and muscle to close the wound. Anti-inflammatory, repercussive and analgesic drugs will be used for 1 week.
Patient will be hospitalized for 1 to 2 weeks after surgery. Blood routine examination, erythrocyte sedimentation rate, immunoglobulin, autoantibodies and clinical examination will be carried out for signs of pain, swelling, immune rejection and infection. Patient will be evaluated at 3 days，3, 6, 12, 18 and 22 months after operation by radiography; Three-dimensional CT scan will be also performed at regular intervals. The function of the body will be evaluated at regular intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients with bone defect and bone nonunion caused by tumor or trauma
- •the length of bone defect in long diaphysis is more than 4cm or more than half of the shaft diameter
- •the size of bone defect is more than 5cmx5cm
- •the patients are unable to use autologous bone graft or other treatments
- •the patients request to use the treatment of tissue-engineered bone
- •Supportive family with willingness to participate in completing questionnaires
排除标准
- •Patients with serious diseases such as hemorrhagic disorders, infection, tumor, contagion and so on.
- •Patients who are pregnant
- •Patients with serious abnormal cardiopulmonary function
- •Patients disagree to use the tissue-engineered bone
- •Patients are older than 60 years
- •Patients who are regarded to be unqualified by investigator
研究组 & 干预措施
allograft bone
traditional allograft bone
干预措施: allograft bone (Device)
tissue-engineered bone
tissue-engineered bone
干预措施: tissue-engineered bone (Device)
结局指标
主要结局
The scores of bone healing
时间窗: within 48 weeks after surgical treatment of bone dect
The scores of bone healing are divided into three kinds: nonhealing: 0; delayed healing: 1; normal healing: 2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
the adverse event incidence using tissue-engineered bone and allograft bone
时间窗: within 24 weeks after surgical treatment of bone dect
the adverse event incidence of tissue-engineered bone is compared with the adverse event incidence of allograft bone to verify the safety of tissue-engineered bone.
次要结局
- The scores of blood routine test(within 48 weeks after surgical treatment of bone dect)
- The scores of C-reactive protein(within 48 weeks after surgical treatment of bone dect)
- The scores of the ratio of complement C3 to complement C4(within 48 weeks after surgical treatment of bone dect)
- The scores of immunoglobulin assay(within 48 weeks after surgical treatment of bone dect)
- The scores of pain(within 48 weeks after surgical treatment of bone dect)
- The scores of erythrocyte sedimentation rate(ESR)(within 48 weeks after surgical treatment of bone dect)
- The scores of duration of hospital stay(within 48 weeks after surgical treatment of bone dect)
- the scores of time of weight loading after operation(within 48 weeks after surgical treatment of bone dect)
- The scores of tumorigenesis(within 48 weeks after surgical treatment of bone dect)
- The scores of treatment course(within 48 weeks after surgical treatment of bone dect)
- The scores of number of operations(within 48 weeks after surgical treatment of bone dect)
- The scores of wound healing of soft tissue(within 48 weeks after surgical treatment of bone dect)