Endocardial Stem Cells Approach Efficacy (ESCAPE)


Tracking Information

Start Date  ICMJEFebruary 2007
Estimated Primary Completion DateFebruary 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  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00841958 on ClinicalTrials.gov Archive Site

Descriptive Information

Brief Title  ICMJEEndocardial Stem Cells Approach Efficacy
Official Title  ICMJEEfficacy 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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEIschemic Heart Failure
Intervention  ICMJEProcedure: 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  ICMJE250
Estimated Completion DateMarch 2011
Estimated Primary Completion DateFebruary 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
GenderBoth
Ages21 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Evgeniy A Pokushalov, Prof.+7 383 332 7655E.Pokushalov@gmail.com
Contact: Alexander B Romanov, MD+7 383 332 7655abromanov@mail.ru

Administrative Information

NCT ID  ICMJENCT00841958
Responsible PartyProf. Pokushalov Evgeniy, Meshalkin Research Institute of Pathology of Circulation
Study ID Numbers  ICMJESCVM-029, RU002
Study Sponsor  ICMJEMeshalkin Research Institute of Pathology of Circulation
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided ByMeshalkin Research Institute of Pathology of Circulation