Cardiac Stem Cell Infusion in Patients With Ischemic CardiOmyopathy (SCIPIO)
Completed · Phase 1
Conditions studied: Coronary Artery Disease, Congestive Heart Failure
In brief
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.
Key facts
- Study ID
- NCT00474461
- Run by
- University of Louisville
- People needed
- 33
- Starts
- 2009-02-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2017-04-11
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- LVEF < 40% (by any imaging modality: echocardiography/SPECT/LV angiography)
- A history of Q-wave MI with a residual akinetic and nonviable scar (as evidenced by low-dose dobutamine stress echocardiogram and/or or thallium redistribution nuclear study for viability and/or an electrocardiogram)
- Patients scheduled for surgical revascularization within few days (< 2 weeks) of the initial screening
You may not qualify if…
- Age >75 by time of infusion
- Cardiogenic shock
- Severe co-morbidities (e.g., renal failure, liver failure)
- Mini-CABG procedures
- Pregnant/nursing women or women of child-bearing potential
- Inability to provide informed consent
- Diabetic Hgb A1c > 8.5%
- Patients with a history of hepatitis B, hepatitis C, and HIV
Where it is running
- Jewish Hospital — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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