Extracorporal Shock Wave Therapy for Induction of Therapeutic Neovascularization and Homing of Bone Marrow Progenitor Cells in Patients With Chronic Ischemic Heart Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Improvement in global ejection fraction on LV angiography
研究概览
简要总结
Extracorporal shock wave therapy is performed prior to cell therapy for induction of therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in patients with chronic ischemic heart disease following anterior myocardial infarction.
Shock waves can induce growth factor expression in the ischemic myocardium and might augment homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h following shock wave therapy
详细描述
Single center, Phase I-II Study (Safety, Feasibility and Efficacy) Double-blind, randomised trial (Cell therapy), single blind (Shockwave)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic ischemic heart disease
- •Patients with anterior myocardial infarction > 3months
- •EF < 50% or NYHA II-IV
- •Age 18-80
- •Informed consent
排除标准
- •Ventricular thrombus
- •Infarct < 3 months.
- •Active infection or fever
- •Chronic inflammatory disease (e.g M. Crohn, Rheumatoid Arthritis)
- •HIV Infection oder active Hepatitis
- •Neoplastic disease w/o complete remission within 5 years
- •Stroke < 3months
- •Creatinine > 2 mg/dl
- •Relevant Liver disease (GOT > twice the upper limit).
- •Anemia (Hemoglobin <10 mg/dl)
- •Thrombocytopenia < 100.000/µl
- •Allergies to Aspirin, Clopidogrel, Heparin
- •History of bleeding disorder
- •History of coagulopathy
- •Gastrointestinal Bleeding < 3 months
- •Surgery or Trauma < 2 months
- •Pregnancy
- •Mental Retardation
- •Participation in other clinical study < 1 month
研究组 & 干预措施
Placebo shock-wave treatment & cell therapy
干预措施: intracoronary stem cell therapy (Procedure)
Low-dose shock wave treatment & Placebo
干预措施: intracoronary stem cell therapy (Procedure)
low-dose shock-wave treatment & Cell therapy
干预措施: intracoronary stem cell therapy (Procedure)
High-dose shock-wave treatment & Placebo
干预措施: intracoronary stem cell therapy (Procedure)
High-dose shock-wave treatment & cell therapy
干预措施: intracoronary stem cell therapy (Procedure)
结局指标
主要结局
Improvement in global ejection fraction on LV angiography
时间窗: 4 months
次要结局
- NT BNP levels(4 months)
- Global or regional wall motion at 4 months and 1 year(4 months)
- MACE(4 months)
- NYHA Class(4 months)
- Life quality(4 months)
研究者
A. M. Zeiher
Prof. Dr. Andreas M. Zeiher
Johann Wolfgang Goethe University Hospital