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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
NOGA XP Cardiac Navigation System
NOGA XP Cardiac Navigation System
Sponsored by
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, bone marrow mononuclear cells

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Almazov Federal National Medical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

group of bone marrow cell therapy

group of sham therapy

Arm Description

Outcomes

Primary Outcome Measures

Change in global left ventricular ejection fraction and regional wall motion score index

Secondary Outcome Measures

Incidence of the major adverse cardiac events

Full Information

First Posted
May 13, 2011
Last Updated
February 11, 2020
Sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
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1. Study Identification

Unique Protocol Identification Number
NCT01354678
Brief Title
Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia
Acronym
IMPI
Official Title
Phase 1 Study to Evaluate the Efficacy and Safety of Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to inefficacy of the tested method
Study Start Date
May 2011 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, bone marrow mononuclear cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group of bone marrow cell therapy
Arm Type
Active Comparator
Arm Title
group of sham therapy
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
NOGA XP Cardiac Navigation System
Other Intervention Name(s)
Cordis Corporation's Biologics Delivery Systems
Intervention Description
Intramyocardial multiple precision injection of bone marrow mononuclear cells
Intervention Type
Procedure
Intervention Name(s)
NOGA XP Cardiac Navigation System
Other Intervention Name(s)
Cordis Corporation's Biologics Delivery Systems
Intervention Description
Intramyocardial multiple precision injection with placebo
Primary Outcome Measure Information:
Title
Change in global left ventricular ejection fraction and regional wall motion score index
Time Frame
6 and12 months
Secondary Outcome Measure Information:
Title
Incidence of the major adverse cardiac events
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene V Shlyakhto, Prof
Organizational Affiliation
Almazov Federal Heart, Blood and Endocrinology Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Almazov Federal National Medical Research Centre
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation

12. IPD Sharing Statement

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

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