Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2007-02-28
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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Autologous bone marrow mononuclear stem cells or peripheral blood stem cells
Cells concentration is 150х106 cells/ml (2ml) with CD34+ cells=2.5±1.44%
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
21 Years
75 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Principal Investigators
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Evgeny A Pokushalov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
State Research Institute of Circulation Pathology
Locations
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State Research Institute of Circulation Pathology
Novosibirsk, , Russia
Countries
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References
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Pokushalov E, Romanov A, Chernyavsky A, Larionov P, Terekhov I, Artyomenko S, Poveshenko O, Kliver E, Shirokova N, Karaskov A, Dib N. Efficiency of intramyocardial injections of autologous bone marrow mononuclear cells in patients with ischemic heart failure: a randomized study. J Cardiovasc Transl Res. 2010 Apr;3(2):160-8. doi: 10.1007/s12265-009-9123-8. Epub 2009 Sep 24.
Related Links
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State Research Institute of Circulation Pathology Official Site
Other Identifiers
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RU002
Identifier Type: OTHER
Identifier Source: secondary_id
SCVM-029
Identifier Type: -
Identifier Source: org_study_id
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