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

Phase 1

Terminated

• Conditions: Heart Failure
• Interventions: Procedure: NOGA XP Cardiac Navigation System

• Registration Number: NCT01354678
• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Primary Completion: 2018-10
• Study Completion: 2019-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group of bone marrow cell therapy	NOGA XP Cardiac Navigation System	-
group of sham therapy	NOGA XP Cardiac Navigation System	-

Primary Outcome Measures

Name	Time	Method
Change in global left ventricular ejection fraction and regional wall motion score index	6 and12 months

Secondary Outcome Measures

Name	Time	Method
Incidence of the major adverse cardiac events	6 and 12 months

Trial Locations

Locations (1)

Almazov Federal National Medical Research Centre; 🇷🇺 Saint-Petersburg, Russian Federation