Cellwave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium - Full Text View

Sponsored by:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00326989

Purpose

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

Condition	Intervention	Phase
Congestive Heart Failure	Procedure: intracoronay stem cell therapy	Phase I Phase II

MedlinePlus related topics: Heart Diseases Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Extracorporal Shock Wave Therapy for Induction of Therapeutic Neovascularization and Homing of Bone Marrow Progenitor Cells in Patients With Chronic Ischemic Heart Disease

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

Improvement in global ejection fraction on LV angiography [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global or regional wall motion at 4 months and 1 year [ Time Frame: 4 months ] [ Designated as safety issue: No ]
NYHA Class [ Time Frame: 4 months ] [ Designated as safety issue: No ]
NT BNP levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
MACE [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Life quality [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	May 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

extracorporal shock waves prior to intracoronary stem cell therapy

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326989

Contacts

Contact: Andreas M Zeiher, MD	069 6301 ext 5789	zeiher@em.uni-frankfurt.de
Contact: Dirk H Walter, MD	+49 69 6301 ext 5710	d.walter@em.uni-frankfurt.de

Locations

Germany
Div. of Cardiology , University of Frankfurt	Recruiting
Frankfurt, Germany, 60590
Contact: Andreas M Zeiher, MD +49 69 6301 ext 5789 zeiher@em.uni-frankfurt.de
Contact: Dirk H Walter, MD +49 69 6301 ext 5710 d.walter@em.uni-frankfurt.de
Principal Investigator: Andreas M Zeiher, MD

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Investigators

Principal Investigator:	Andreas M Zeiher, MD	Div. of Cardiology, University of Frankfurt, Germany
Study Director:	Dirk H Walter, MD	Div. of Cardiology, University of Frankfurt

More Information

Responsible Party:	Div. of Cardiology, University of Frankfurt ( Prof. Andreas Zeiher )
Study ID Numbers:	2005-005709-50, Cellwave CHF
Study First Received:	May 16, 2006
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00326989
Health Authority:	Germany: Paul-Ehrlich-Institut; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:

Extracorporal shock wave therapy
Cell therapy

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Shock

Myocardial Ischemia
Neovascularization, Pathologic
Ischemia

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009