Optimisation d'un Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans l'ischémie Critique Des Membres inférieurs liée à l'athérosclérose
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Healing
研究概览
简要总结
This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).
详细描述
Patients will be included with CLI according to the TASC criteria. Under general anesthesia, 500 ml of bone marrow is harvested in both iliac crests. After isolation and concentration of the BMMNC in 30 ml, 40 injections of around 0.75 ml will be done in the gastrocnemius of the ischemic leg, within 3 hours after preparation of the cell therapy product.
Patients will then be followed-up every week during one month and then every month during one year.
This study was approved by the ethical committee of Paris-Broussais HEGP (France) and our french regulatory agency (AFSSAPS).
It began including patients in January 2005 and will last until December 2007.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age > 18
- •Signature of informed consent
- •Critical leg ischemia with ankle pressure < 70 mmHg
- •Ischemic ulcer or gangrene
- •No possibility of surgical revascularization
- •No possibility of angioplasty
排除标准
- •Suspicion of a cancer on X-Ray, mammography or elevated PSA
- •Age < 18
- •Life expectancy < 6 months
- •Active retinopathy
- •Angioplasty or surgical revascularization within 3 months
- •Stoke within 3 months
- •HIV + or HCV/HBC+
结局指标
主要结局
Healing
时间窗: 1 year
Amputation rate
时间窗: 1 year
Ankle brachial index
时间窗: 6 months
次要结局
- TcPO2(6 months)