Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
Several studies have documented that transplantation of bone marrow-derived cells (BMC)
following acute myocardial infarction is associated with a reduction in infarct scar size and
improvements in left ventricular function and perfusion. The available evidence in humans
suggests that BMC transplantation is associated with improvements in physiologic and anatomic
parameters in both acute myocardial infarction and chronic ischemic heart disease, above and
beyond the conventional therapy. In particular, intracoronary application of BMC is proved to
be safe and was associated with significant improvement in the left ventricular ejection
fraction (LVEF) in patients with chronic heart failure.
In contrast to ischemic heart failure, the data on effects of BMC transplantation in patients
with dilated cardiomyopathy are limited to pre-clinical studies. In a rat model of dilated
cardiomyopathy, intramyocardial delivery of pluripotent mesenchymal cells improved LVEF,
possibly through induction of myogenesis and angiogenesis, as well as by inhibition of
myocardial fibrosis, suggesting that the beneficial effects of stem cell transplantation in
dilated cardiomyopathy may primarily be related to their ability to supply large amounts of
angiogenic, antiapoptotic, and mitogenic factors. Similarly, transplantation of cocultured
mesenchymal stem cells and skeletal myoblasts was shown to improve LVEF in a murine model of
Chagas disease.
Study Aim:
To define the clinical effects of BMC transplantation in dilated cardiomyopathy in a pilot
clinical study investigating the effects of intracoronary CD34+ cell transplantation on
functional, structural, neurohormonal, and electrophysiologic parameters in patients with
end-stage dilated cardiomyopathy.
Phase:
Phase 2
Details
Lead Sponsor:
University Medical Centre Ljubljana
Collaborators:
Blood Transfusion Centre of Slovenia Stanford University