Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Improvement in myocardial perfusion measured by SPECT
研究概览
简要总结
Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.
The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.
详细描述
Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.
The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.
4o patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 12 months follow-up.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 to 80 years Reversible ischemia on a stress SPECT Angina pectoris CCS class >_ 2 Reduced exercise time < 10 min No further revascularization options
排除标准
- •Pregnant Present or history of cancer Proliferative retinopathy Systemic severe disease LVEF < 25 % NYHA > II
研究组 & 干预措施
Mesenchymal stromal cell
Mesenchymal stromal cell
干预措施: stem cell (Biological)
结局指标
主要结局
Improvement in myocardial perfusion measured by SPECT
时间窗: 6 months after treatment
次要结局
- Safety(6 months after treatment)
- Improvement in myocardial perfusion and function measured by PET and MR(6 months after treatment)
- Exercise time(6 months after treatment)
- Clinical angina status(6 months after treatment)
研究者
JKastrup
Professor
Rigshospitalet, Denmark