Ignite Creation Date:
2024-05-05 @ 11:32 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01350310
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2011-05-06
Brief Title:
Safety and Efficacy Study of Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
Intramyocardial Stem Cell Therapy in Patients With 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:
NOGA-DCM
Brief Summary:
BACKGROUND In patients with non-ischemic dilated cardiomyopathy intracoronary stem cell transplantation has been shown to improve exercise capacity reduce ventricular remodelling and improve 1-year survival Pre-clinical data demonstrate that stem cell effects on the diseased heart can be further enhanced by direct intramyocardial delivery route
AIMS
1 To evaluate safety and efficacy of intramyocardial stem cell therapy in patients with non-ischemic dilated cardiomyopathy
2 To directly compare clinical effects of intracoronary and intramyocardial stem cell delivery
METHODS Of 60 patients with dilated cardiomyopathy 30 will be randomized to intramyocardial transplantation of CD34 cells Study Group and 30 will receive intracoronary stem cell therapy Control Group In both groups peripheral blood stem cells will be mobilised by daily subcutaneous injections of filgrastim CD34 cells will be collected via apheresis and labelled with technetium In the Study Group electromechanical mapping will be used to identify viable myocardium and intramyocardial injections in the target areas will be performed with NOGA catheter In the Control group patients will undergo myocardial perfusion scintigraphy and CD34 cells will be injected intracoronary in the artery supplying segments of reduced viability Patients will be followed for 1 year Primary endpoints will include changes in left ventricular ejection fraction and left ventricular dimensions measured by echocardiography Secondary endpoints will include changes in exercise capacity and changes in NT-proBNP values
HYPOTHESES
1 At 1 year intramyocardial stem cell therapy will be associated with improved left ventricular ejection fraction reduced left ventricular dimensions improved exercise capacity and reduced levels of NT-proBNP
2 Beneficial effects of intramyocardial stem cell therapy will be superior to those observed with intracoronary stem cell delivery
AIMS
1 To evaluate safety and efficacy of intramyocardial stem cell therapy in patients with non-ischemic dilated cardiomyopathy
2 To directly compare clinical effects of intracoronary and intramyocardial stem cell delivery
METHODS Of 60 patients with dilated cardiomyopathy 30 will be randomized to intramyocardial transplantation of CD34 cells Study Group and 30 will receive intracoronary stem cell therapy Control Group In both groups peripheral blood stem cells will be mobilised by daily subcutaneous injections of filgrastim CD34 cells will be collected via apheresis and labelled with technetium In the Study Group electromechanical mapping will be used to identify viable myocardium and intramyocardial injections in the target areas will be performed with NOGA catheter In the Control group patients will undergo myocardial perfusion scintigraphy and CD34 cells will be injected intracoronary in the artery supplying segments of reduced viability Patients will be followed for 1 year Primary endpoints will include changes in left ventricular ejection fraction and left ventricular dimensions measured by echocardiography Secondary endpoints will include changes in exercise capacity and changes in NT-proBNP values
HYPOTHESES
1 At 1 year intramyocardial stem cell therapy will be associated with improved left ventricular ejection fraction reduced left ventricular dimensions improved exercise capacity and reduced levels of NT-proBNP
2 Beneficial effects of intramyocardial stem cell therapy will be superior to those observed with intracoronary stem cell delivery
Detailed Description:
None
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