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

Johann Wolfgang Goethe University Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Congestive Heart Failure

Treatments: Procedure: intracoronary stem cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00326989

2005-005709-50

Cellwave CHF

Details and patient eligibility

About

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

Full description

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

Enrollment: 103 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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103 participants in 5 patient groups

Low-dose shock wave treatment & Placebo

Active Comparator group

Treatment:

Procedure: intracoronary stem cell therapy

low-dose shock-wave treatment & Cell therapy

Active Comparator group

Treatment:

Procedure: intracoronary stem cell therapy

High-dose shock-wave treatment & Placebo

Active Comparator group

Treatment:

Procedure: intracoronary stem cell therapy

High-dose shock-wave treatment & cell therapy

Active Comparator group

Treatment:

Procedure: intracoronary stem cell therapy

Placebo shock-wave treatment & cell therapy

Active Comparator group

Treatment:

Procedure: intracoronary stem cell therapy