Cardiac Stem Cell Infusion in Patients With Ischemic CardiOmyopathy (SCIPIO) (SCIPIO)
The purpose of this study is to investigate the safety of intracoronary cardiac stem cells (CSCs) therapy in humans. Currently, there is no effective intervention to regenerate (regrow) dead heart muscle after a heart attack.
The central hypothesis is that CSCs infused into nonviable myocardial segments will regenerate infarcted myocardium by differentiating into cardiomyocytes and other cell types. According to our hypothesis, CSC infusion regenerates myocardium with consequent improvement in contractile function of the heart and general clinical status.
|Coronary Artery Disease Congestive Heart Failure||Biological: Treatment group||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Myocardial Regeneration Using Cardiac Stem Cells Harvested From Right Atrial Appendages in Patients With Ischemic Cardiomyopathy.|
- Monitoring adverse outcomes, death, sustained/symptomatic ventricular tachycardia, infection, bleeding, MI, stroke, peripheral embolism in the hospital after drug administration, in the first month after injection, and serially afterwards. [ Time Frame: 1.5 years ]
|Study Start Date:||February 2009|
|Study Completion Date:||September 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment group
Patients in this arm received intracoronary expanded autologous c-kit positive cardiac stem cells.
Biological: Treatment group
Intracoronary injection of cardiac stem cells
Other Name: Intracoronary Injection (cardiac stem cell therapy)
No Intervention: Control group
Patients in this arm did not receive any intervention.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00474461
|United States, Kentucky|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Roberto Bolli, MD||University of Louisville|