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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00474461
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : April 11, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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

  Show Detailed Description

Study Design

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
Primary Completion Date : August 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

Arms and Interventions

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


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

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