Endocardial Stem Cells Approach Efficacy

NCT00841958 | Completed Phase 3 DMC

• 2 other identifiers: SCVM-029RU002
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Autologous bone marrow mononuclear stem cells or peripheral blood stem cells PROCEDURE

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

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

Related 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 failure: a randomized study. J Cardiovasc Transl Res. 2010 Apr;3(2):160-8. doi: 10.1007/s12265-009-9123-8. Epub 2009 Sep 24.

  PMID: 20560030 RESULT

Related Links

• State Research Institute of Circulation Pathology Official Site

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Evgeny A Pokushalov, MD, PhD

  State Research Institute of Circulation Pathology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 12, 2009
• Study Start: February 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

RU (1)