Cardiac Stem Cell Infusion in Patients With Ischemic CardiOmyopathy (SCIPIO) (SCIPIO)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

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Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Locations

United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

University of Louisville

Brigham and Women's Hospital

Jewish Hospital and St. Mary's Healthcare

Investigators

Principal Investigator:	Roberto Bolli, MD	University of Louisville

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chugh AR, Beache GM, Loughran JH, Mewton N, Elmore JB, Kajstura J, Pappas P, Tatooles A, Stoddard MF, Lima JA, Slaughter MS, Anversa P, Bolli R. Administration of cardiac stem cells in patients with ischemic cardiomyopathy: the SCIPIO trial: surgical aspects and interim analysis of myocardial function and viability by magnetic resonance. Circulation. 2012 Sep 11;126(11 Suppl 1):S54-64.

Bolli R, Chugh AR, D'Amario D, Loughran JH, Stoddard MF, Ikram S, Beache GM, Wagner SG, Leri A, Hosoda T, Sanada F, Elmore JB, Goichberg P, Cappetta D, Solankhi NK, Fahsah I, Rokosh DG, Slaughter MS, Kajstura J, Anversa P. Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial. Lancet. 2011 Nov 26;378(9806):1847-57. doi: 10.1016/S0140-6736(11)61590-0. Epub 2011 Nov 14.

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
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