Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01354678
Recruitment Status : Terminated (Terminated due to inefficacy of the tested method)
First Posted : May 17, 2011
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: NOGA XP Cardiac Navigation System Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Actual Study Start Date : May 2011
Actual Primary Completion Date : October 2018
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Russian Federation
Almazov Federal National Medical Research 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
Layout table for investigator information
Principal Investigator: Eugene V Shlyakhto, Prof Almazov Federal Heart, Blood and Endocrinology Centre
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal 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    
Other Study ID Numbers: IMPI-1
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
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:
Layout table for MeSH terms
Heart Failure
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases