Treatment of No-option CLI Patients 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
- Amputation free survival
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 no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. Amputation free survival,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 no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. 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. Amputation free survival will be evaluated at , 1 , 3, 6 and 12 months after PB-MNC therapy.
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
- None
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 no-option CLI who presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months
排除标准
- •Recent myocardial infarction
- •Severe valvular heart disease
- •After organ transplantation
- •Cardiomyopthy( EF< 25%)
- •Liver failure
- •Coagulopathy
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 and Aspirin 81 mg/day and supportive treatment including wound care and pain killer drug.
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 and supportive treatment including wound care and pain killer drug.
干预措施: No-PB-MNC therapy (Drug)
结局指标
主要结局
Amputation free survival
时间窗: 3 month
Rate of non amputated limb
次要结局
- Toe brachial index (TBI)(1,3,6,12 month)
- Amputation free survival(1,6,12 month)
- Ankle brachial index (ABI)(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)