Endocardial Stem Cells Approach Efficacy

Phase 3

Completed

• Conditions: Myocardial Ischemia

• Registration Number: NCT00841958
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-23
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	2007-2010

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation