Endocardial Stem Cells Approach Efficacy

Myocardial Ischemia Clinical Trial

— ESCAPE  

Official title:

Efficacy of the Endocardial Stem Cells Implantation in Ischemic Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841958
• Other study ID #: SCVM-029
• Secondary ID: RU002
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2009
• Last updated: April 23, 2012
• Start date: February 2007
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 (?ABG 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Procedure:
• Autologous bone marrow mononuclear stem cells or peripheral blood stem cells
Cells concentration is 150?106 cells/ml (2ml) with CD34+ cells=2.5±1.44%

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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 fail — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Null Hypothesis (Ho): There is no survival benefit in the stem cells group compared to the control group ( isolate MED therapy). H0: ? = 1 Alternative Hypothesis (Ha): There is a survival benefit in the stem cells group. HA: ? > 1		2007-2010	Yes

External Links

•   State Research Institute of Circulation Pathology Official Site