Evaluation the Treatment of Nonunion of Long Bone Fracture of Lower Extremities (Femur and Tibia) Using Mononuclear Stem Cells From the Iliac Wing Within a 3-D Tissue Engineered Scaffold
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 18
- 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. Also for better result we used the mesenchymal stem cells with BMP2 in collagenic scaffold. The collagen has a osteoconductive effect and BMP2 and stem cells has a osteoinductive effect therefore this combination is useful in filling the gap in non union site and irritate the union rate.
Mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure. 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 within a 3-D tissue engineered scaffold 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(infection,malignancy,local or systemic allergic reaction)(12 months)
研究者
mohammad taghi peivandi
MD
Emdadi Kamyab Hospital