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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-007699-40 |
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The purpose of this clinical trial is to evaluate the feasibility, safety and efficacy of left ventricular endocardial injection of guided bone marrow-derived cardiopoietic cells (C-Cure) in the setting of chronic heart failure secondary to ischemic cardiomyopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Optimal standard of care + C-Cure |
|
| 2 | No Intervention | Optimal standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-Cure | Biological | Intraventricular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular ejection fraction | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-min walking distance | 6 months, 1 and 2 years | |
| Quality of Life | 6 months, 1 and 2 years | |
| All cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jozef Bartunek, MD, PhD | VZW Cardiovascular Research Center Aalst | Principal Investigator |
| André Terzic, MD, PhD | Mayo Clinic, Rochester, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CardioVascular Center | Aalst | 9300 | Belgium | |||
| Université Catholique de Louvain, Saint-Luc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23583246 | Derived | Bartunek J, Behfar A, Dolatabadi D, Vanderheyden M, Ostojic M, Dens J, El Nakadi B, Banovic M, Beleslin B, Vrolix M, Legrand V, Vrints C, Vanoverschelde JL, Crespo-Diaz R, Homsy C, Tendera M, Waldman S, Wijns W, Terzic A. Cardiopoietic stem cell therapy in heart failure: the C-CURE (Cardiopoietic stem Cell therapy in heart failURE) multicenter randomized trial with lineage-specified biologics. J Am Coll Cardiol. 2013 Jun 11;61(23):2329-38. doi: 10.1016/j.jacc.2013.02.071. Epub 2013 Apr 10. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Each follow-up |
| Cardiovascular events | Each follow-up |
| Brussels |
| 1200 |
| Belgium |
| Centre Hospitalier Universitaire | Charleroi | 6000 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Ziekenhuis Oost Limburg | Genk | 3600 | Belgium |
| Virga Jesse Ziekenhuis | Hasselt | 3500 | Belgium |
| Centre Hospitalier Universitaire | Liège | 4000 | Belgium |
| Clinical Center of Serbia | Belgrade | 11000 | Serbia |