Endocardial Stem Cells Approach Efficacy (ESCAPE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT00841958
First received: February 10, 2009
Last updated: April 23, 2012
Last verified: April 2012

February 10, 2009
April 23, 2012
February 2007
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00841958 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Endocardial Stem Cells Approach Efficacy
Efficacy of the Endocardial Stem Cells Implantation in Ischemic Heart Failure Patients

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Myocardial Ischemia
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%
Not Provided
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. Epub 2009 Sep 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00841958
SCVM-029, RU002
Yes
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Principal Investigator: Evgeny A Pokushalov, MD, PhD State Research Institute of Circulation Pathology
Meshalkin Research Institute of Pathology of Circulation
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP