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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01354678
First Posted: May 17, 2011
Last Update Posted: August 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health:

Primary Outcome Measures:
  • Change in global left ventricular ejection fraction and regional wall motion score index [ Time Frame: 6 and12 months ]

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

Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: August 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354678


Locations
Russian Federation
Almazov Federal Heart, Blood and Endocrinology Centre
Saint-Petersburg, Russian Federation, 197341
Sponsors and Collaborators
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Investigators
Principal Investigator: Eugene V Shlyakhto, Prof Almazov Federal Heart, Blood and Endocrinology Centre
  More Information

Responsible Party: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
ClinicalTrials.gov Identifier: NCT01354678     History of Changes
Other Study ID Numbers: IMPI-1
First Submitted: May 13, 2011
First Posted: May 17, 2011
Last Update Posted: August 2, 2016
Last Verified: August 2016

Keywords provided by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health:
heart failure
bone marrow mononuclear cells

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