Cell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium

Extracorporal Shock Wave Therapy for Induction of Therapeutic Neovascularization and Homing of Bone Marrow Progenitor Cells in Patients With Chronic Ischemic Heart Disease

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

Single center, Phase I-II Study (Safety, Feasibility and Efficacy) Double-blind, randomised trial (Cell therapy), single blind (Shockwave)

Inclusion Criteria:

• Patients with chronic ischemic heart disease
• Patients with anterior myocardial infarction > 3months
• EF < 50% or NYHA II-IV
• Age 18-80
• Informed consent

Exclusion Criteria:

• 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