Safety and Efficacy Study of Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy (NOGA-DCM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Medical Centre Ljubljana
Sponsor:
Collaborators:
The Methodist Hospital System
Stanford University
Information provided by (Responsible Party):
Bojan Vrtovec, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01350310
First received: May 6, 2011
Last updated: April 9, 2013
Last verified: April 2013

May 6, 2011
April 9, 2013
March 2011
December 2013   (final data collection date for primary outcome measure)
Changes in left ventricular ejection fraction and dimensions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Standard 2D and Doppler echocardiography will be performed at baseline, and repeated at 1 month, 3 months, 6 months and 1 year after the procedure. Left ventricular ejection fraction will be measured using Simpson's method and left ventricular end-systolic and end-diastolic dimensions will be measured according to standard echocardiography protocol.
Same as current
Complete list of historical versions of study NCT01350310 on ClinicalTrials.gov Archive Site
  • Changes in exercise capacity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Exercise capacity will be evaluated with 6-minute walk test at baseline, and again at 1,3,6 and 12 months after the procedure.
  • Change in NT-proBNP levels [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Plasma levels of NT-proBNP will be measured at baseline, and again at 1, 3, 6 and 12 months after the procedure.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy
Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Dilated Cardiomyopathy
  • Chronic Heart Failure
  • Procedure: Intramyocardial injection
    Electromechanical mapping will be used to identify viable myocardium (unipolar voltage >6.9 mV) and intramyocardial injections in the target areas will be performed with NOGA catheter (25 injections of 0.3 cc).
  • Procedure: Intracoronary injection
    Patients will undergo myocardial perfusion scintigraphy for myocardial viability assessment. Microcatheter will be placed in the mid segment of the coronary artery supplying the segments of reduced tracer accumulation and repeated intracoronary injections of stem cell solution will be performed.
  • Procedure: Intramyocardial injection
    Procedure/Surgery: Intramyocardial injection Electromechanical mapping will be used to identify viable myocardium (unipolar voltage >6.9 mV) and intramyocardial injections in the target areas will be performed with NOGA catheter (25 injections of 0.3 cc).
  • Experimental: Intramyocardial Injections
    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.
    Intervention: Procedure: Intramyocardial injection
  • Active Comparator: Intracoronary Injections
    Peripheral blood stem cells will be mobilised by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labelled with technetium. Patients will undergo myocardial perfusion scintigraphy and CD34+ cells will be injected intracoronary in the artery supplying segments of reduced viability. Nuclear imaging for quantitation of myocardial retention rates of labeled cells will be performed at 2 and 18 hours after the procedure.
    Intervention: Procedure: Intracoronary injection
  • Active Comparator: Ischemic heart disease
    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
    Intervention: Procedure: Intramyocardial injection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Bojan Vrtovec, MD, PhD +3861 522 1148 bojan.vrtovec@gmail.com
Contact: Gregor Poglajen, MD gregor.poglajen@gmail.com
Slovenia
 
NCT01350310
NOGA-DCM
No
Bojan Vrtovec, University Medical Centre Ljubljana
University Medical Centre Ljubljana
  • The Methodist Hospital System
  • Stanford University
Not Provided
University Medical Centre Ljubljana
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP