The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- clinical and radiological union at 1 month to 6 months
研究概览
简要总结
Because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union on the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. Therefore the investigators decide to inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure to non union site in patient that are resistant to other treatment. Then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment.clinical union consider to relief pain in non union site and be stable in examination.
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
- 是
入选标准
- •Every patient with non union in the site of long bone fracture
- •Age more than 18 and under 60 years old
- •Fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction.
- •No infection in site of surgery
- •Be able and willing to participate in the study
- •Written informed consent
排除标准
- •Evidence of malignancy
- •Pregnancy or breastfeeding
- •Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing
结局指标
主要结局
clinical and radiological union at 1 month to 6 months
时间窗: 6 months
patients receiving Mesenchymal Stem Cells that develop a partial or complete callus at 1, 2, 3, 4 ,5 and 6 months evaluate with standard X-rays
次要结局
- •Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects.(12 months)
- Incidence of adverse events in patients (e.g infection , malignancy , ...) Adverse events will be continuously monitored(12 months)
研究者
mohammad taghi peivandi
MD
Emdadi Kamyab Hospital