Ischemic Dilated Cardiomyopathy Clinical Trial
Official title:
A Controlled Open Label Phase II Study Assessing the Efficacy of Intracoronary Autologous Mesenchymal Stem Cells in Patients With Ischemic Dilated Cardiomyopathy
Despite the recent advances in medical and surgical treatment, heart failure resulting from ischemic cardiomyopathy (ICM) remains the leading cause of cardiovascular mortality. Ischemic dilated cardiomyopathy(ICM) is defined as abnormally enlarged left ventricular (LV) cavity with documented poor LV function as a result of severe coronary artery disease (CAD). LV remodelling which is inevitable after an infarct has been postulated to contribute largely to the poor outcome of patients with ICM, therefore prevention of LV remodelling is the goal for the treatment in patients with severe CAD. Cell therapy represents a novel therapeutic strategy for treating cardiac diseases including severe CAD and heart failure. A type of stem cells known as mesenchymal stem cells(MSCs)can be isolated from bone marrow.This study aims to test the differentiation potential and therapeutic capacity of MSC from severe CAD patients after intracoronary implantation in an ischemic myocardial environment in Malaysian population.
Ischemic dilated cardiomyopathy(ICM) is defined as abnormally enlarged left ventricular (LV)
cavity with documented poor LV function as a result of severe coronary artery disease (CAD).
LV remodelling which is inevitable after an infarct has been postulated to contribute
largely to the poor outcome of patients with ICM, therefore prevention of LV remodelling is
the goal for the treatment in patients with severe CAD. Cell therapy represents a novel
therapeutic strategy for treating cardiac diseases including severe CAD and heart failure. A
type of stem cells known as mesenchymal stem cells(MSCs)can be isolated from bone marrow.
Experimental and clinical studies to date have shown that mesenchymal stem cells represent
the most suitable cell type for regeneration therapy after myocardial infarction (MI). After
injection into ischemic myocardium, bone marrow-derived MSC (BM-MSC) from various animal
species can differentiate into multiple cell lineages, including endothelial cells and
cardiomyocytes, thereby improving LV function.
In Malaysia we have previously demonstrated our capability in isolating and extracting MSC
from a small volume of bone marrow aspirates.The isolation, expansion and feasibility of
storage, transport and differentiation of human MSC for clinical application has been
performed locally. The researchers used autologous BM-MSC, ex vivo expanded, on three
patients with end-stage ischemic dilated cardiomyopathy who were on the heart transplant
waiting list and each patient was injected with MSCs directly into the myocardium during
open heart surgery. After twelve months, all patients remained alive and well with
significant improvement in cardiac function, quality of life and other parameters including
reduction of myocardial scar volume as seen from cardiac scans.
The same group of researchers further carried out a study on ten patients with severe
dilated cardiomyopathy and refractory cardiac function despite maximum medical therapy to
receive autologous BM-MSC implantation via intramyocardial or intracoronary route. All
patients remained alive at 1 year while recorded significant improvements in LV ejection
fraction and other LV parameters from baseline to 6 and 12 months. Reduction in scar was
also noted in six of the patients by 12 months.
Following these results, this study aims to test the differentiation potential and
therapeutic capacity of MSC from severe CAD patients after intracoronary implantation in an
ischemic myocardial environment in Malaysian population.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment