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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00326989

Enrollment

103

Registered

2006-05-17

Start date

2006-05-31

Completion date

2011-12-31

Last updated

2017-03-21

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

Conditions

Congestive Heart Failure

Keywords

Extracorporal shock wave therapy, Cell therapy

Brief summary

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

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

Interventions

PROCEDUREintracoronary stem cell therapy

extracorporal shock waves prior to intracoronary cell therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Improvement in global ejection fraction on LV angiography	4 months

Secondary

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026