Cell Therapy in Critical Limb Ischemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 40
- 试验地点
- 20
- 主要终点
- Major amputation rate and mortality
研究概览
简要总结
BALI (Bone marrow Autograft in Limb Ischemia) is a randomized double-blind trial comparing implantation of bone marrow - mononuclear cells versus placebo in patients presenting with critical leg ischemia and no surgical option.
The main end point is the survival without major amputation 6 months after implantation.
Biological studies are performed on bone marrow mononuclear cells (BM-MNC) to evaluate their angiogenic properties.
详细描述
One hundred and ten patients with critical leg ischemia and no surgical option will be included. A bone marrow harvest (500 mL under general anaesthesia) is performed and BM-MNC are separated and concentrated (30 mL) for all included patients. For half of them, the BM-MNC are implanted on the same day whereas the others are implanted with a placebo cell-product (30 mL saline with 4 ml peripheral blood). For these patients the BM-MNC are cryo-conserved. Only the cell therapy unit, neither the patient, nor the clinician, know whether BM-MNC or placebo is implanted. The main end point is the survival without major amputation 6 months after implantation. After this delay it is possible to use previously cryo-conserved BM-MNC. Likewise biological studies are performed on BM-MNC: flow-cytometry analysis of progenitor cells content, proteins and mRNAs expression, induced angiogenesis in animal models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Critical limb ischemia
- •No possible surgical treatment
排除标准
- •Ongoing infectious disease
- •Gangrene extending beyond the digits
- •Diabetes mellitus with HbA1c > 7.5% or with proliferative retinopathy
- •History of malignant disease
- •Contra-indication to general anaesthesia
- •Chronic haemodialysis
- •Prothrombin Time < 50%
- •Recent onset (within 3 months) of myocardial infarction or brain infarction
- •Contra-indication to modification of anti-platelet or anticoagulant therapy
- •History of heparin-induced thrombocytopenia
- •Unexplained haematological abnormality
结局指标
主要结局
Major amputation rate and mortality
时间窗: 6 months
次要结局
- Clinical symptoms and haemodynamical parameters(6 months)