Status:
COMPLETED
Endocardial Stem Cells Approach Efficacy
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Myocardial Ischemia
Eligibility:
All Genders
21-75 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to test that endocardial stem cells implantation in patients who have CAD, low ejection fraction and signs of HF without possibility of CABG and PCI or despite o...
Eligibility Criteria
Inclusion
- Men and women who are not of childbearing potential
- Age 21-75 years.
- Patients with CAD, NYHA and CCS angina III-IV functional class
- LVEF less than 35% measured by echocardiography or SPECT within three months of study entry
- Unsuitable for initial or repeated conventional revascularization (CABG or PCI)
Exclusion
- Failure to provide informed consent.
- Plan for PCI or CABG.
- Non-cardiac illness with a life expectancy of less than 3 year.
- Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
- Previous heart, kidney, liver, or lung transplantation.
- Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.
- Recent acute myocardial infarction (AMI) within 90 days of study entry
- Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment
- History of moderate to severe aortic stenosis or prosthetic aortic valve
- Permanent atrial fibrillation
- Thrombosis in LV, based on echocardiography data
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00841958
Start Date
February 1 2007
End Date
December 1 2011
Last Update
April 24 2012
Active Locations (1)
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1
State Research Institute of Circulation Pathology
Novosibirsk, Russia, 630055