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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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


Condition Intervention Phase
Heart Failure
Procedure: NOGA XP Cardiac Navigation System
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1 Study to Evaluate the Efficacy and Safety of Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia

Resource links provided by NLM:


Further study details as provided by Almazov Federal Center of Heart, Blood and Endocrinology:

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

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

Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group of bone marrow cell therapy Procedure: NOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection of bone marrow mononuclear cells
Other Name: Cordis Corporation's Biologics Delivery Systems
Sham Comparator: group of sham therapy Procedure: NOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection with placebo
Other Name: Cordis Corporation's Biologics Delivery Systems

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354678

Locations
Russian Federation
Almazov Federal Heart, Blood and Endocrinology Centre Recruiting
Saint-Petersburg, Russian Federation, 197341
Contact: Dmitry S Lebedev, Prof    +78127023537    lebedevdmitry@mail.ru   
Contact: Olga M Moiseeva, Prof    +78127026816    moiseeva@almazovcentre.ru   
Sub-Investigator: Dmitry V Kryzhanovsky, PhD         
Sub-Investigator: Sergey V Anisimov, PhD         
Sponsors and Collaborators
Almazov Federal Center of Heart, Blood and Endocrinology
Investigators
Principal Investigator: Eugene V Shlyakhto, Prof Almazov Federal Heart, Blood and Endocrinology Centre
  More Information

No publications provided

Responsible Party: Almazov Federal Center of Heart, Blood and Endocrinology
ClinicalTrials.gov Identifier: NCT01354678     History of Changes
Other Study ID Numbers: IMPI-1
Study First Received: May 13, 2011
Last Updated: January 10, 2014
Health Authority: Russia: Ethics Committee

Keywords provided by Almazov Federal Center of Heart, Blood and Endocrinology:
heart failure
bone marrow mononuclear cells

Additional relevant MeSH terms:
Coronary Artery Disease
Heart Failure
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014