Myocardial Regeneration Using Cardiac Stem Cells Harvested From Right Atrial Appendages in Patients With Ischemic Cardiomyopathy. (SCIPIO)

NCT00474461 Phase 1 COMPLETED

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.

Details

Lead sponsor	University of Louisville
Phase	Phase 1
Status	COMPLETED
Enrolment	33
Start date	2009-02
Completion	2013-09

Conditions

• Coronary Artery Disease
• Congestive Heart Failure

Interventions

• Treatment group

Primary outcomes

• 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. — 1.5 years

Countries

United States