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

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01354678
• Other study ID #: IMPI-1
• Status: Terminated
• Phase: Phase 1
• Start date: May 2011
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Failure
• Ischemia
• Myocardial Ischemia

Intervention

Procedure:
• NOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection of bone marrow mononuclear cells
• NOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection with placebo

Locations

Country	Name	City	State
Russian Federation	Almazov Federal National Medical Research Centre	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in global left ventricular ejection fraction and regional wall motion score index		6 and12 months
Secondary	Incidence of the major adverse cardiac events		6 and 12 months