Chronic Ischemic Heart Disease Clinical Trial
Official title:
METHOD - Phase I/II Study of Intramyocardial Injection of Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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