Extracorporal shock wave therapy for induction of therapeutic neovascularization and homing of bone marrow progenitor cells in patients with chronic ischemic heart disease - Cell-Wave-CHF

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005709-50-DE

Enrollment

100

Registered

2006-01-09

Start date

2006-05-05

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with ischemic coronary artery disease (congestive heart failure) and s/p anterior myocardial infarction

Interventions

Product Name: Autologous Progenitor Cells Pharmaceutical Form: Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intracoronary use Product Name: Shock Waves (Bio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: · Patients with chronic ischemic cardiomyopathy · s/p anterior myocardial infarction > 3 months · 18-80 years · Male or female · Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: · Myocardial infarction 2 mg/dl) before treatment · Liver disease (GOT > 2x upper limit, or spontaneous INR > 1,5). · Anemia (Hemoglobin < 10 mg/dl) · Platelets <100.000/µl · Known allergies to aspirin, clopidogrel or heparin · bleeding disorder · gastrointestinal bleeding within last 3 months · surgery or trauma < 2 months · pregnancy · mental retardation · Inclusion in other study within last 30 days

Design outcomes

Primary

Measure	Time frame
Main Objective: Main goal is the combination therapy of extracorporal shock waves prior to intracoronary cell therapy to induce cardiac regeneration and improve left ventricular remodeling and global or regional LV-Function. Shock waves increase growth factors and may induce homing of progenitor cell to the target tissue ;Secondary Objective: Patients will be randomised to 5 groups High dose Shock waves + Cell therapy or placebo Low dose Shock waves + Cell therapy or placebo Placebo Shock waves + Cell therapy;Primary end point(s): Improvement of global LV-function as assessed by LV-angiography or MRT.	—

Measure

Time frame

Main Objective: Main goal is the combination therapy of extracorporal shock waves prior to intracoronary cell therapy to induce cardiac regeneration and improve left ventricular remodeling and global or regional LV-Function. Shock waves increase growth factors and may induce homing of progenitor cell to the target tissue ;Secondary Objective: Patients will be randomised to 5 groups High dose Shock waves + Cell therapy or placebo Low dose Shock waves + Cell therapy or placebo Placebo Shock waves + Cell therapy;Primary end point(s): Improvement of global LV-function as assessed by LV-angiography or MRT.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026