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
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment group
Patients in this arm received intracoronary expanded autologous c-kit positive cardiac stem cells.
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Biological: Treatment group
Intracoronary injection of cardiac stem cells
Other Name: Intracoronary Injection (cardiac stem cell therapy)
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No Intervention: Control group
Patients in this arm did not receive any intervention.
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- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

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 | |
Jewish Hospital | |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: | Roberto Bolli, MD | University of Louisville |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Roberto Bolli, Chief of the Division of Cardiovascular Medicine, University of Louisville |
ClinicalTrials.gov Identifier: | NCT00474461 History of Changes |
Other Study ID Numbers: |
IOIC070833 |
First Posted: | May 17, 2007 Key Record Dates |
Last Update Posted: | April 11, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Keywords provided by Roberto Bolli, University of Louisville:
coronary artery disease Heart Attack Heart failure Cardiac Stem Cells Coronary Artery Bypass |
Additional relevant MeSH terms:
Heart Failure Coronary Artery Disease Myocardial Ischemia Coronary Disease Cardiomyopathies |
Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |