Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty: A Randomized Controlled Clinical Trial in Diabetic Patients With Below the Knee Critical Limb Ischemia
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- Restenosis rate
研究概览
简要总结
The main aim of the present study was to evaluate the therapeutic potential and safety of transarterial infusion of granulocyte colony stimulating factor (G-CSF) mobilized cluster of differentiation (CD) 133(+) cells when combined with percutaneous transluminal angioplasty (PTA) in treatment of below the knee (BTK) peripheral arterial disease (PAD) in diabetic patients.
详细描述
CD133+ cell, a bone marrow derived subpopulation of adult hematopoietic progenitor cells, confers high proliferative, vasculogenic and regenerative capacity in vitro and in vivo. thereby suggesting that CD133+ cells may induce vasculogenesis, improve limb perfusion, prevent tissue loss and restore ambulatory function in patients with critical limb ischemia. Although several small, randomized trials have been conducted so far demonstrating safety of autologous cells of bone marrow origin for the treatment, the reported benefits were found to be variable. A meta-analysis of autologous bone marrow derived cell therapy for critical limb ischemia trials suggested that application of autologous stem cell transplantation in curing limb ischemic patients does not have obviously effectiveness in the improvement of ankle brachial pressure (ABI) of the limb ischemic patients. But it can dramatically reduce the rate of amputation.
Therefore, in the present study, the investigators aim to evaluate the therapeutic potential and safety of transarterial infusion of g-csf-mobilized CD 133(+) cells when combined with PTA in treatment of below the knee PAD in diabetic patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-75 years , Gender: Both
- •Patients with below the knee limb ischemia with diabetes.
- •Rutherford class 2-
- •Target lesions with a diameter reduction of at least 50% and have an occlusion of longer than 4 cm on angiography.
- •Have no previous history of any stem cell therapy [infusion of CD133 endothelial progenitor cell (EPC)].
- •Written informed consent signed by the patients or representatives. -
排除标准
- •Previous bypass surgery or stent placement at the ipsilateral lower limb
- •History of intolerance to antiplatelet therapy, heparin, or contrast media.
- •Presence of any of the following conditions:
- •severe liver disease (such as ascites, esophageal varices, liver transplantation);
- •hemodynamic instability;
- •Severely impaired renal function (serum creatinine level > 2.5 mg/dL).
- •Receiving immunosuppressive therapy;
- •History of decompensated heart failure (New York Heart Association class III or IV and level) or myocardial infarction, or heart bypass surgery;
- •Bleeding diathesis;
- •Active systemic bacterial infection;
- •Acute thrombophlebitis or deep vein thrombosis of the target limb; 4) Pregnant or lactating women, or women of child bearing age unable or unwilling to use effective contraception during the study period; 5) Expected survival time of less than 24 months -
结局指标
主要结局
Restenosis rate
时间窗: 12 months
Occurrence of \> 50% of restenosis in the treated vessel after 12 months as assessed by digital substraction angiography (DSA) (Efficacy endpoints).
Peak systolic velocity ratio
时间窗: 12 months
Peak systolic velocity ratio ≥ 2.4 by Doppler's ultrasonography for patients who did not undergo angiography after 12 months (Efficacy endpoints).
Severe adverse effects (SAEs)
时间窗: 12 months
Number of SAEs per subject across actual treatment cohorts (Safety Endpoint).
次要结局
- ABI value(6 and 12 months)
- Transcutaneous oxygen pressures (TcPO2)(6 and 12 months)
- Amputation-free survival (AFS)(6 and 12 months)
- Rutherford classification(6 and 12 months)
- Rest pain(6 and 12 months)
- Six Minute Walk test(6 and 12 months)
- Ulcer healing rate(6 and 12 months)
研究者
Maoquan Li
Prof. Dr. Li
Shanghai 10th People's Hospital