Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Bone Defects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- fulfill bone cyst defect
研究概览
简要总结
There are two types of bone cysts, unicameral and aneurismal. These cysts happen to anyone, but they are most commonly seen in children and young adults while their bones are still growing. Living with a bone cyst and determining treatment options depend on the type of cyst.
Non-surgical treatments for unicameral bone cysts involves repeated X-rays in individuals who do not experience any symptoms.
Surgical removal of a unicameral bone cyst is needed if it becomes especially painful, or the area of the bone starts to thin out. The investigators aim to assess the clinical efficacy and side effects of mesenchymal stem cells seeded on bone matrix in repairing bone cyst.
详细描述
Bone cysts are benign lesions usually discovered in children from age of 5 to 15 years. Treatment options include observation, corticosteroid injection and surgery. Sometimes the risk of surgery is comparable to the likelihood of fracture without treatment. In orthopedic surgery, bone chips , various types of ceramics, natural and synthetized bone mineral hydroxyapatite and tricalcium phosphate, as well as numerous polymers and co-polymers of alfa-hydroxy acids are used to perform as an osteoconductive and rarely osteoinductive factor to help bone formation.Some evidence demonstrated that bone marrow mesenchymal stem cells deposited on the surface of this constructs enhance its osteogenic differentiation. In this study the investigators seeds cultured bone marrow derived mesenchymal stem cells on bone matrix, to evaluate its therapeutic potential in repairing unicameral or aneurysmal bone cyst.This composite is placed in the bone cyst after its curettage during a surgery.Post-operation assessment is done by X-Ray examination and MRI at 1, 2, 6, and 12 months after treatment.
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bone cyst diagnosed with MRI, CT-scan, or X-Ray
- •Intact cyst wall with high risk for fracture
- •Cysts with minimum diameter of 6mm
- •Diagnostic test performed on cyst fluid
- •Provided written consent form
排除标准
- •Patients with diagnosis of cancer
- •Patients enrolled in other clinical trial
研究组 & 干预措施
bone cyst
Patients with bone cyst defect are injected with mesenchymal cells.
干预措施: cell injection (Biological)
结局指标
主要结局
fulfill bone cyst defect
时间窗: 6 months
Defect of bone due to cyst fulfill after cell transplantation.
次要结局
- effect of mesenchymal cell transplantation(6 months)