Endocardial Stem Cells Approach Efficacy (ESCAPE)
Tracking Information
Start Date ICMJE | February 2007 |
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Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: February 11, 2009) | Null Hypothesis (Ho): There is no survival benefit in the stem cells group compared to the control group ( isolate MED therapy). H0: Ө ≤ 1 Alternative Hypothesis (Ha): There is a survival benefit in the stem cells group. HA: Ө > 1 [ Time Frame: 2007-2010 ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00841958 on ClinicalTrials.gov Archive Site |
Descriptive Information
Brief Title ICMJE | Endocardial Stem Cells Approach Efficacy |
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Official Title ICMJE | Efficacy of the Endocardial Stem Cells Implantation in Ischemic Heart Failure Patients |
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 on previous revascularization improves long-term survival compared to MED alone |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Ischemic Heart Failure |
Intervention ICMJE | Procedure: 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% |
Recruitment Information
Estimated Enrollment ICMJE | 250 | ||||||||
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Estimated Completion Date | March 2011 | ||||||||
Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 21 Years to 75 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Administrative Information
NCT ID ICMJE | NCT00841958 |
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Responsible Party | Prof. Pokushalov Evgeniy, Meshalkin Research Institute of Pathology of Circulation |
Study ID Numbers ICMJE | SCVM-029, RU002 |
Study Sponsor ICMJE | Meshalkin Research Institute of Pathology of Circulation |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Meshalkin Research Institute of Pathology of Circulation |
Source: http://clinicaltrials.gov/