Pilot Study of Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease (STEMPAD Trial)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Major limb amputation rate as defined by amputations of the limb that are transmetarsal and higher
研究概览
简要总结
This study is designed to test the use of G-CSF in peripheral vascular disease. The investigators hypothesize that mobilization of angiogenic cells into the blood by granulocyte colony stimulating factor (G-CSF) may stimulate the formation of new blood vessels and result in a sustained improvement in blood flow in patients with severe peripheral arterial disease.
详细描述
One fourth of patients with peripheral artery disease (PAD) of the lower extremities have severe symptomatic disease and 1-2% have critical limb ischemia (CLI). In patients with CLI, the risk of limb amputation at 1 year is 50%. In addition, patients with CLI often have rest pain, non-healing ulcers and severe limitations of ambulation. Revascularization procedures, including bypass surgery, percutaneous transluminal angioplasty and angioplasty with stenting, are currently the only treatment options. However, many patients are not eligible for a revascularization procedure due to small vessel disease or coexisting medical problems. Moreover, restenosis rates are high.
There is currently no effective non-invasive treatment for critical limb ischemia. We hypothesize that mobilization of angiogenic cells into the blood by granulocyte colony stimulating factor (G-CSF) may stimulate angiogenesis in areas of ischemia and result in a sustained improvement in blood flow in patients with severe PAD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have critical limb ischemia secondary to PAD, as defined by the presence of a non-healing ulcer, rest pain, or dry gangrene.
- •Patients must have a toe pressure ≤ 30 mm Hg.
- •Patients must be ≥18 years old.
- •Patient must be able to self-administer a daily subcutaneous injection or have a caregiver who is able to administer a daily subcutaneous injection.
- •Patients must be taking or have no absolute contraindication to taking aspirin and clopidogrel. If they are not currently taking aspirin, they must be willing to take aspirin (81 mg daily) and clopidogrel (75 mg daily) for 14 days starting on the first day of G-CSF treatment.
- •After being informed of the treatment involved, patients must give written consent. The patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment. A built-in period of one week from discussion of the trial and initiation of the trial will be mandatory for enrollment.
排除标准
- •Patients with transmetatarsal or higher amputations in the affected limb are excluded.
- •Patients who are candidates for a revascularization procedure.
研究组 & 干预措施
G-CSF
干预措施: G-CSF (Drug)
G-CSF
干预措施: Aspirin (Drug)
G-CSF
干预措施: Clopidogrel (Drug)
Placebo
干预措施: Clopidogrel (Drug)
Placebo
干预措施: Placebo (Drug)
Placebo
干预措施: Aspirin (Drug)
结局指标
主要结局
Major limb amputation rate as defined by amputations of the limb that are transmetarsal and higher
时间窗: 1 year
次要结局
- Toe pressure index(Up to 1 year)
- Ankle-brachial index(Up to 1 year)
- Ulcer healing as measured by surface area and depth(Up to 1 year)
- Improvement in rest pain as measured by the Vascular Quality of Life Questionnaire(Up to 1 year)