NCT01211028已完成1 期
Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Number and Nature of Adverse Events : safety and tolerability
研究概览
简要总结
The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in patients with critical leg ischemia.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe peripheral vascular disease not amenable to bypass or angioplasty
- •Age >40 years old
- •Normal renal function (creatinine < 1.6)
- •Non pregnant female
- •Lifespan > 6 months
排除标准
- •Age <40 years old
- •Refusal to give informed consent and/orCognitively disabled
- •Congestive heart failure or stroke in the last 3 months
- •History of cancer or myeloproliferative disorders
- •Proliferative retinopathy
- •Pregnancy
- •Positive screening test for HIV, Hepatitis B or Hepatitis C
- •Buerger patient
- •Cachexia or predicted impossibility for a biopsy of at least 30 grams of fat tissue
- •Pregnancy or lactation
- •Having been non controlled severe pathology
结局指标
主要结局
Number and Nature of Adverse Events : safety and tolerability
时间窗: 15 days, 1, 2, 3, 4,5, 6 months for adverse events record
To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. \[ Designated as safety issue: Yes \]
次要结局
未报告次要终点
研究者
研究点 (2)
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