Cardiac Stem Cell Infusion in Patients With Ischemic CardiOmyopathy (SCIPIO) (SCIPIO)
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|ClinicalTrials.gov Identifier: NCT00474461|
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : April 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Congestive Heart Failure||Biological: Treatment group||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Myocardial Regeneration Using Cardiac Stem Cells Harvested From Right Atrial Appendages in Patients With Ischemic Cardiomyopathy.|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||September 2013|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474461
|United States, Kentucky|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Roberto Bolli, MD||University of Louisville|