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

Study Overview
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Brief Summary
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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

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

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

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Procedure: intracoronary stem cell therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low-dose shock wave treatment & Placebo<br> | Procedure: intracoronary stem cell therapy<br>* extracorporal shock waves prior to intracoronary cell therapy<br>|
| Active Comparator: low-dose shock-wave treatment & Cell therapy<br> | Procedure: intracoronary stem cell therapy<br>* extracorporal shock waves prior to intracoronary cell therapy<br>|
| Active Comparator: High-dose shock-wave treatment & Placebo<br> | Procedure: intracoronary stem cell therapy<br>* extracorporal shock waves prior to intracoronary cell therapy<br>|
| Active Comparator: High-dose shock-wave treatment & cell therapy<br> | Procedure: intracoronary stem cell therapy<br>* extracorporal shock waves prior to intracoronary cell therapy<br>|
| Active Comparator: Placebo shock-wave treatment & cell therapy<br> | Procedure: intracoronary stem cell therapy<br>* extracorporal shock waves prior to intracoronary cell therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in global ejection fraction on LV angiography |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global or regional wall motion at 4 months and 1 year |  | 4 months | 
| NYHA Class |  | 4 months | 
| NT BNP levels |  | 4 months | 
| MACE |  | 4 months | 
| Life quality |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporal shock wave therapy, Cell therapy