Pilot Study of Investigation of Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Feasibility of the full procedure
研究概览
简要总结
Left Ventricular Assist Devices are commonly used to assist failing hearts as a bridge to transplantation or for long-term support. The purpose of the MESenchymal stem cell therapy and Left Ventricular Assist Device program is to improve heart function with stem cell therapy and attempt to wean patients from HeartMate Left Ventricular Assist Device.
详细描述
Currently Left Ventricular Assist Device-only patients are being implanted and followed. Feasibility of autologous mesenchymal stem cell grafting in patients receiving heart mate will be assessed in a 4 patient pilot trial. Mesenchymal stem cell are delivered during Left Ventricular Assist Device surgery by intramyocardial infusions. Recovery of contractile function of the heart is assessed during attempts to wean patients from Left Ventricular Assist Device
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
autologous mesenchymal stem cells
After bone-marrow aspiration by an authorized person, Mesenchymal Stem Cells were isolated and cultured during 17 days by the French Blood Establishment. Then, patients receive intramyocardial injections of Mesenchymal Stem Cells during Left Ventricular Assist Device surgery
干预措施: Autologous mesenchymal stem cells (Drug)
结局指标
主要结局
Feasibility of the full procedure
时间窗: 1 month
ability to perform bone marrow aspiration, cell culture and intramyocardial injections during left Ventricular Assist Device surgery Realization of a full injection procedure
次要结局
- Ejection Fraction(12 months)
- Measure of heart pressures(12 months)
- Brain natriuretic peptide(12 months)
- Walking distance in 6 minutes(12 months)
- weaning procedure(12 months)
- Troponin(12 months)
- Deaths(1 month)
- Maximal Oxygen consumption(12 months)
- Quality of life(12 months)
- Systemic embolism(1 month)
- Major bleeding(1 month)