Endocardial Stem Cells Approach Efficacy

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00841958

Acronym

ESCAPE

Enrollment

250

Registered

2009-02-12

Start date

2007-02-28

Completion date

2011-12-31

Last updated

2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

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

Interventions

PROCEDUREAutologous bone marrow mononuclear stem cells or peripheral blood stem cells

Cells concentration is 150х106 cells/ml (2ml) with CD34+ cells=2.5±1.44%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026