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

This study has been completed.
Brigham and Women's Hospital
Jewish Hospital and St. Mary's Healthcare
Information provided by (Responsible Party):
Roberto Bolli, University of Louisville Identifier:
First received: May 15, 2007
Last updated: April 8, 2017
Last verified: April 2017

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: Treatment group
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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:

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 ]

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: 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.

  Show Detailed Description


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00474461

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
Principal Investigator: Roberto Bolli, MD University of Louisville
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Roberto Bolli, Chief of the Division of Cardiovascular Medicine, University of Louisville Identifier: NCT00474461     History of Changes
Other Study ID Numbers: IOIC070833
Study First Received: May 15, 2007
Last Updated: April 8, 2017
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by 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
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on April 24, 2017