Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia (IMPI)

This study is currently recruiting participants.

Verified January 2012 by Almazov Federal Center of Heart, Blood and Endocrinology

Sponsor:

Information provided by (Responsible Party):

Almazov Federal Center of Heart, Blood and Endocrinology

ClinicalTrials.gov Identifier:

NCT01354678

First received: May 13, 2011

Last updated: January 24, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 13, 2011

Last Updated Date

January 24, 2012

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in global left ventricular ejection fraction and regional wall motion score index [ Time Frame: 6 and12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01354678 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of the major adverse cardiac events [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia

Official Title ^ICMJE

Phase 1 Study to Evaluate the Efficacy and Safety of Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia

Brief Summary

Randomised placebo-controlled study of efficiency and safety of bone marrow mononuclear cells transplantation by intramyocardial multiple precision injection in ischemic heart failure patients.

Detailed Description

The increase of prevalence of heart failure in human population requires to develop new and effective methods of treatment. One of them is stem cells transplantation into a myocardial tissue, which cause the improvement of contractility, myocardial remodelling after myocardial infarction (MI), dilated cardiomyopathy, etc. Use of autologous stem cells does not require of immunosuppressive therapy and does not correlate with some ethical problems. Clinical application of mesenchymal stem cells always requires a step of culturing, which is associated with increased risk of contamination Therefore haemopoietic stem cells, endothelial progenitor cells or mononuclear bone marrow cells are often used to be transplant for treatment of heart failure (HF) patients.Using NOGA XP Cardiac Navigation System improves specificity of transplantations, that is decisive.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Procedure: NOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection of bone marrow mononuclear cells

Other Name: Cordis Corporation's Biologics Delivery Systems
Procedure: NOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection with placebo

Other Name: Cordis Corporation's Biologics Delivery Systems

Study Arm (s)

Active Comparator: group of bone marrow cell therapy
Intervention: Procedure: NOGA XP Cardiac Navigation System
Sham Comparator: group of sham therapy
Intervention: Procedure: NOGA XP Cardiac Navigation System

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2015

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients with coronary artery disease (CAD) and HF II-III NYHA class
MI more than 6 months before the study
LVEF less than 35%
absence of indication to coronary revascularization
optimal pharmacological therapy no less than 8 weeks
heart transplantation is contraindicated
patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)
patients giving informed consent

Exclusion Criteria:

acute coronary syndrome
coronary revascularization less than 6 months
patients requiring surgical correction of post-MI aneurism
LV wall thickness less than 5 mm in site of possible injection
patients with CRT implanted within 3 month before cells injection
clinically significant associated diseases

Gender

Both

Ages

18 Years to 69 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Russian Federation

Administrative Information

NCT Number ^ICMJE

NCT01354678

Other Study ID Numbers ^ICMJE

IMPI-1

Has Data Monitoring Committee

Responsible Party

Almazov Federal Center of Heart, Blood and Endocrinology

Study Sponsor ^ICMJE

Almazov Federal Center of Heart, Blood and Endocrinology

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eugene V Shlyakhto, Prof

Almazov Federal Heart, Blood and Endocrinology Centre

Information Provided By

Almazov Federal Center of Heart, Blood and Endocrinology

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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