Ignite Creation Date:
2024-05-05 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00629018
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2008-02-25
Brief Title:
Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
The Effects of Autologous Intracoronary Stem Cell Transplantation In Patients With End-Stage Dilated Cardiomyopathy
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Patients were randomly allocated in a 11 ratio to receive intracoronary transplantation of autologous CD34 stem cells SC group or no intracoronary infusion control group At the time of enrollment and at yearly intervals thereafter we performed detailed clinical evaluation echocardiography 6-minute walk test and measured plasma levels of NT-proBNP To better-define the potential role of inflammatory response we also measured plasma inflammatory markers tumor necrosis factor TNF-α and interleukin IL-6 at the time of CD34 stem cell injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None