Overview

This trial is active, not recruiting.

Condition heart failure
Treatments noga xp cardiac navigation system
Phase phase 1
Sponsor Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Start date May 2011
End date May 2016
Trial size 30 participants
Trial identifier NCT01354678, IMPI-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
noga xp cardiac navigation system Cordis Corporation's Biologics Delivery Systems
Intramyocardial multiple precision injection of bone marrow mononuclear cells
(Sham Comparator)
noga xp cardiac navigation system Cordis Corporation's Biologics Delivery Systems
Intramyocardial multiple precision injection with placebo

Primary Outcomes

Measure
Change in global left ventricular ejection fraction and regional wall motion score index
time frame: 6 and12 months

Secondary Outcomes

Measure
Incidence of the major adverse cardiac events
time frame: 6 and 12 months

Eligibility Criteria

Male or female participants from 18 years up to 69 years old.

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

Additional Information

Official title Phase 1 Study to Evaluate the Efficacy and Safety of Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia
Principal investigator Eugene V Shlyakhto, Prof
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health.