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| ID | Type | Description | Link |
|---|---|---|---|
| Cellwave CHF |
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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
Single center, Phase I-II Study (Safety, Feasibility and Efficacy) Double-blind, randomised trial (Cell therapy), single blind (Shockwave)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose shock wave treatment & Placebo | Active Comparator |
| |
| low-dose shock-wave treatment & Cell therapy | Active Comparator |
| |
| High-dose shock-wave treatment & Placebo | Active Comparator |
| |
| High-dose shock-wave treatment & cell therapy | Active Comparator |
| |
| Placebo shock-wave treatment & cell therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intracoronary stem cell therapy | Procedure | extracorporal shock waves prior to intracoronary cell therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in global ejection fraction on LV angiography | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Global or regional wall motion at 4 months and 1 year | 4 months | |
| NYHA Class | 4 months | |
| NT BNP levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas M Zeiher, MD | Div. of Cardiology, University of Frankfurt, Germany | Principal Investigator |
| Dirk H Walter, MD | Div. of Cardiology, University of Frankfurt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Div. of Cardiology , University of Frankfurt | Frankfurt | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23592107 | Derived | 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. | |
| 22936827 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 4 months |
| MACE | 4 months |
| Life quality | 4 months |
| 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. |