Endocardial Stem Cells Approach Efficacy (ESCAPE)

Meshalkin Research Institute of Pathology of Circulation

Status and phase

Completed

Phase 3

Conditions

Myocardial Ischemia

Treatments

Procedure: Autologous bone marrow mononuclear stem cells or peripheral blood stem cells

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00841958

SCVM-029

RU002 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

250 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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