Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients with chronic ischemic heart disease and LVEF \< 40%. The primary objective is to determine whether the administration of the cells improves recovery of the left ventricular function. Secondary objective is the finding of clinical or paraclinical parameters to predict potential benefits of the treatment (basing on MRI characteristics such as size, transmurality of the myocardial infarction and peri-lesional ischemia). In the first part of the study 10 patients are treated without control group. This phase serves as feasibility and safety part of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
only intramyocardial, NOGA guided injection on BM cells.
combination of intramyocardial, NOGA guided injection of BM cells and intracoronary injection of those cells
initially no intervention; crossover to therapy 6 months after enrollment
Cardiocentro Ticino
Lugano, Switzerland
Troponin samples
Measurements of Troponine after cell injection
Time frame: 1 day after cell injection
Number of patients with adverse events at short term
Time frame: within 1 week after cell injection
Number of patients with adverse events at mid/long term
Time frame: up to 12 months after cell injection
change in LVEF
First 10 patients + following randomization phase (n = 54); assessment of short term safety (1 week), Adverse events within 1 year; efficacy measurements 6 months after treatment
Time frame: 6 months vs. baseline
change in Quality of life
Time frame: 6 months vs. baseline
change in Vo2 max
change in functional status (Vo2 max)
Time frame: 6 months vs. bl
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