Brief Title
Safety and Efficacy Study of Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy
Official Title
Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Changes in left ventricular ejection fraction and dimensions
Secondary Outcome
Changes in exercise capacity
Condition
Dilated Cardiomyopathy
Intervention
Intramyocardial injection
Study Arms / Comparison Groups
Intramyocardial Injections
Description: Peripheral blood stem cells will be mobilised by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labelled with technetium. Electromechanical mapping will be used to identify viable myocardium and intramyocardial injections in the target areas will be performed with NOGA catheter. Nuclear imaging for quantitation of myocardial retention rates of labeled cells will be performed at 2 and 18 hours after the procedure.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
110
Start Date
March 2011
Completion Date
December 2014
Primary Completion Date
August 2014
Eligibility Criteria
Inclusion Criteria: - Established dg. of dilated CMP (defined according to ESC position statement - absence of any stenotic lesions on coronary angiography, no congenital heart disease, no primary valve disease on echocardiography, and no history of hypertension or alcohol abuse1) - left ventricular ejection fraction < 30% - NYHA functional class III or IV for at least 3 months before referral - Optimal medical management for at least 6 months Exclusion Criteria: - Left ventricular aneurysm or thrombus - Hematologic disease - Multiorgan failure - Active malignancy
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Slovenia
Location Countries
Slovenia
Administrative Informations
NCT ID
NCT01350310
Organization ID
NOGA-DCM
Responsible Party
Principal Investigator
Study Sponsor
University Medical Centre Ljubljana
Collaborators
The Methodist Hospital System
Study Sponsor
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Verification Date
April 2015