Treatment of Intermittent Claudication by G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain free walking distance
研究概览
简要总结
This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months
详细描述
This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months in the control group and day of randomization, 1 , 3, 6 and 12 months after injection of PB-MNC in the experiment group. Pain free walking distance will be evaluated at the day of randomization, 1 , 3, 6 and 12 months by pedometer.
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 (Outcomes Assessor)
盲法说明
The assessor who measure the pain free walking distance, ABI, TBI,TCOM do not know the result of randomization
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic arterial occlusive disease who presented with intermittent claudication
排除标准
- •Recent myocardial infarction
- •Severe valvular heart disease
- •After organ transplantation
- •Cardiomyopthy( EF< 25%)
- •Liver failure
- •Coagulopathy
- •Pregnancy
研究组 & 干预措施
PB-MNC therapy
The patientsin PB-MNC therapy group will be injected with G-CSF mobilized PB-MNC into calf or thigh muscle of ischemic limb, Aspirin 81 mg/day, cilostazol 200 mg/day and walking exercise 3 times per week.
干预措施: PB-MNC therapy (Procedure)
No PB-MNC therapy
In patients in No PB-MNC therapy, they will receive aspirin 81 mg/day, cilostazol 200 mg/day and walking exercise 3 times per week.
干预措施: No PB-MNC therapy (Drug)
结局指标
主要结局
Pain free walking distance
时间窗: 3 month
the maximum distance which patient could walk without pain
次要结局
- Ankle brachial index (ABI)(1,3,6,12 month)
- Toe brachial index (TBI)(1,3,6,12 month)
- Transcutaneous oxygen measurement (TCOM)(1,3,6,12 month)
- 36-Item Short Form Health Survey (SF36)(1,3,6,12 month)
- Pain free walking distance(1,6,12 month)