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Cardiac Stem Cell Infusion in Patients With Ischemic CardiOmyopathy (SCIPIO) (SCIPIO)
This study has been completed.
Sponsor:
University of Louisville
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: April 8, 2017
Last verified: April 2017
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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: 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 Roberto Bolli, 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
Eligibility| 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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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
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
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 |
| Study First Received: | May 15, 2007 |
| Last Updated: | April 8, 2017 |
| Individual Participant Data | |
| 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 |
ClinicalTrials.gov processed this record on June 23, 2017