Clinical TrialEffects of Intracoronary Stem Cell Transplantation in Patients With Dilated Cardiomyopathy
Section snippets
Patient Population
This study consists of an open-label randomized study design conducted at the Advanced Heart Failure and Transplantation Center at University Medical Center Ljubljana between January 1, 2008, and September 1, 2008, in collaboration with the Methodist DeBakey Heart Center and Stanford University.
Patients with heart failure referred to Advanced Heart Failure and Transplantation Center at University Medical Center Ljubljana were considered for inclusion in the study. Inclusion criteria consisted
Patient Characteristics
Of 61 patients entering Phase 1, we excluded 1 patient because of improvement of cardiac function and 5 patients with inadequate neutrophil rise after G-CSF stimulation. The remaining 55 patients were randomly allocated into SC group (n = 28) and control group (n = 27). A flowchart of the study design is presented in Figure 1. In either Phase I or Phase 1 or Phase 2, there have been no G-CSF-related cardiovascular adverse events, and the troponin levels remained normal throughout the
Discussion
In this pilot, open-label randomized study, we investigated the clinical effects of intracoronary administration of autologous bone marrow-derived stem cells in patients with dilated cardiomyopathy. Although our sample size was small, we were able to demonstrate successful engraftment of transplanted stem cells and improvement in left ventricular systolic function (LVEF) and exercise capacity at 12 months. The potential beneficial effects of SC therapy in patients with DCM were also supported
Conclusions
The results of this pilot randomized trial suggest that intracoronary delivery of autologous CD34+ cells represents a safe and effective technique that improves left ventricular function and clinical status of patients with dilated cardiomyopathy, which may be associated with better 1-year outcome. Further, larger studies are warranted to better define the underlying mechanisms and to investigate whether or not these findings may also translate into improved long-term survival of patients with
Disclosures
None.
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Stem cell therapy in heart failure: Where do we stand today?
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Clinical Trial Registration Information: Clinicaltrials.gov identifier: NCT00629018.
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