Mesenchymal Stem Cell Transplantation in the Treatment of Osteonecrosis of the Femoral Head
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The femoral head blood-supply artery angiographies and the areas of femoral head necrosis
研究概览
简要总结
Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. The investigators will infuse expanded autologous MSCs and BMMNCs into patients with osteonecrosis of the femoral head. The study purpose is to examine whether this treatment will result in improvement in osteonecrosis of the femoral head.
详细描述
Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. Patients in this study will receive infusion of expanded autologous MSC and BMMNCs. The puncture of femoral artery will be conducted with digital subtraction angiography(DSA), and the tubes will be inserted into medial femoral circumflex artery,lateral femoral circumflex artery and obturatou artey. The study will evaluate the safety and effectiveness of MSC infusion in patients with osteonecrosis of the femoral head. This study will last for 5 years. Patients will undergo infusions at Day 0. Afterward, patients will be evaluated for response, and undergo X-ray examination, CT and MR scanning at a 6-month interval.
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages: 12 to 60 years old.
- •Association Research Circulation Osseous(ARCO) Classification criteria for osteonecrosis of the femoral head: ARCO phase I and phase II.
- •Able to give informed consent.
排除标准
- •Pregnant women.
- •Previous history of malignancy
- •Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
- •Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in the past 6 months.
- •Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
- •Any illness that in the opinion of the investigator would jeopardize the ability of the Patient to tolerate this treatment.
结局指标
主要结局
The femoral head blood-supply artery angiographies and the areas of femoral head necrosis
时间窗: 2
次要结局
- Coxa joint paining(2)
- Walking distance(2)
- Joint functions(2)
- Life(2)
研究者
Jianming Tan
Director
Fuzhou General Hospital