Cell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium
NCT ID: NCT00326989
Last Updated: 2017-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
103 participants
INTERVENTIONAL
2006-05-31
2011-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low-dose shock wave treatment & Placebo
intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
low-dose shock-wave treatment & Cell therapy
intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
High-dose shock-wave treatment & Placebo
intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
High-dose shock-wave treatment & cell therapy
intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
Placebo shock-wave treatment & cell therapy
intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
Interventions
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intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
Eligibility Criteria
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Inclusion Criteria
* Patients with anterior myocardial infarction \> 3months
* EF \< 50% or NYHA II-IV
* Age 18-80
* Informed consent
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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A. M. Zeiher
Prof. Dr. Andreas M. Zeiher
Principal Investigators
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Andreas M Zeiher, MD
Role: PRINCIPAL_INVESTIGATOR
Div. of Cardiology, University of Frankfurt, Germany
Dirk H Walter, MD
Role: STUDY_DIRECTOR
Div. of Cardiology, University of Frankfurt
Locations
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Div. of Cardiology , University of Frankfurt
Frankfurt, , Germany
Countries
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References
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Assmus B, Walter DH, Seeger FH, Leistner DM, Steiner J, Ziegler I, Lutz A, Khaled W, Klotsche J, Tonn T, Dimmeler S, Zeiher AM. Effect of shock wave-facilitated intracoronary cell therapy on LVEF in patients with chronic heart failure: the CELLWAVE randomized clinical trial. JAMA. 2013 Apr 17;309(15):1622-31. doi: 10.1001/jama.2013.3527.
Leistner DM, Seeger FH, Fischer A, Roxe T, Klotsche J, Iekushi K, Seeger T, Assmus B, Honold J, Karakas M, Badenhoop K, Frantz S, Dimmeler S, Zeiher AM. Elevated levels of the mediator of catabolic bone remodeling RANKL in the bone marrow environment link chronic heart failure with osteoporosis. Circ Heart Fail. 2012 Nov;5(6):769-77. doi: 10.1161/CIRCHEARTFAILURE.111.966093. Epub 2012 Aug 30.
Other Identifiers
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Cellwave CHF
Identifier Type: -
Identifier Source: secondary_id
2005-005709-50
Identifier Type: -
Identifier Source: org_study_id
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