心脏干细胞输注缺血性心肌病患者I期临床试验
2011-11-15 21:53:00   来源：   

Cardiac Stem Cell Infusion in Patients With Ischemic CardiOmyopathy (SCIPIO)
This study is ongoing, but not recruiting participants.

First Received on May 15, 2007.   Last Updated on August 30, 2011   History of Changes
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
   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 Procedure: Intracoronary Injection (cardiac stem cell therapy) Phase I

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 Attack 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 ]

Estimated Enrollment: 40
Study Start Date: February 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
Procedure: Intracoronary Injection (cardiac stem cell therapy)
Intracoronary injection of cardiac stem cells
   Show Detailed Description
   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
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
Responsible Party: Roberto Bolli, University of Louisville
ClinicalTrials.gov Identifier: NCT00474461     History of Changes

Other Study ID Numbers: IOIC070833
Study First Received: May 15, 2007
Last Updated: August 30, 2011
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
Myocardial Ischemia
Coronary Disease
Heart Failure
Cardiomyopathies Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 15, 2011