Safety and Efficacy Study of Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy
Condition: Dilated Cardiomyopathy; Chronic Heart Failure
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): Intramyocardial injection; Intracoronary injection; Intramyocardial injection
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 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).; 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/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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart failure; Dilated cardiomyopathy; Stem cells