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

This study is currently recruiting participants.
Verified January 2014 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 10, 2014
Last verified: January 2014

May 13, 2011
January 10, 2014
May 2011
May 2014   (final data collection date for primary outcome measure)
Change in global left ventricular ejection fraction and regional wall motion score index [ Time Frame: 6 and12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01354678 on ClinicalTrials.gov Archive Site
Incidence of the major adverse cardiac events [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia
Phase 1 Study to Evaluate the Efficacy and Safety of Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Heart Failure
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
May 2015
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 69 Years
No
Not Provided
Russian Federation
 
NCT01354678
IMPI-1
No
Almazov Federal Center of Heart, Blood and Endocrinology
Almazov Federal Center of Heart, Blood and Endocrinology
Not Provided
Principal Investigator: Eugene V Shlyakhto, Prof Almazov Federal Heart, Blood and Endocrinology Centre
Almazov Federal Center of Heart, Blood and Endocrinology
January 2014

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