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

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country250 target enrollmentFebruary 2007

ConditionsMyocardial Ischemia

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Myocardial Ischemia
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 250
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

December 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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