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

This study has been completed.

Sponsor:

Collaborators:

Brigham and Women's Hospital

Jewish Hospital and St. Mary's Healthcare

Information provided by (Responsible Party):

Roberto Bolli, University of Louisville

ClinicalTrials.gov Identifier:

NCT00474461

First received: May 15, 2007

Last updated: October 15, 2014

Last verified: October 2014

History of Changes

Purpose

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	Intervention	Phase
Coronary Artery Disease Congestive Heart Failure	Biological: Intracoronary Injection (cardiac stem cell therapy)	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Myocardial Regeneration Using Cardiac Stem Cells Harvested From Right Atrial Appendages in Patients With Ischemic Cardiomyopathy.

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy Coronary Artery Disease Heart Failure

U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]


Enrollment:	33
Study Start Date:	February 2009
Study Completion Date:	September 2013
Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment group Patients in this arm received intracoronary expanded autologous c-kit positive cardiac stem cells.	Biological: Intracoronary Injection (cardiac stem cell therapy) Intracoronary injection of cardiac stem cells
No Intervention: Control group Patients in this arm did not receive any intervention.

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Eligibility


Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474461

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

No publications provided by University of Louisville

Additional 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
Study First Received:	May 15, 2007
Last Updated:	October 15, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Louisville:


coronary artery disease Heart Attack Heart failure Cardiac Stem Cells Coronary Artery Bypass

Additional relevant MeSH terms:


Coronary Artery Disease Coronary Disease Heart Failure Myocardial Ischemia Arterial Occlusive Diseases	Arteriosclerosis Cardiovascular Diseases Heart Diseases Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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