Please select the arm or intervention descriptions that belong to the clinical trial below.
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.


Options:
A: Arm Label: Intracoronary; Type: EXPERIMENTAL; Interventions: Other: Bone marrow derived progenitor cells or placebo infusion | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo infusion | Intervention Type: OTHER; Name: Bone marrow derived progenitor cells or placebo infusion; Assigned to Arm(s): Intracoronary | Intervention Type: OTHER; Name: Placebo infusion; Assigned to Arm(s): Placebo
B: Arm Label: Intramyocardial Injections; Type: EXPERIMENTAL; Interventions: Procedure: Intramyocardial injection | Arm Label: Intracoronary Injections; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Intracoronary injection | Arm Label: Ischemic heart disease; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Intramyocardial injection | Intervention Type: PROCEDURE; Name: Intramyocardial injection; Assigned to Arm(s): Intramyocardial Injections | Intervention Type: PROCEDURE; Name: Intracoronary injection; Assigned to Arm(s): Intracoronary Injections | Intervention Type: PROCEDURE; Name: Intramyocardial injection; Assigned to Arm(s): Ischemic heart disease
C: Arm Label: Ixmyelocel-T; Type: EXPERIMENTAL; Interventions: Biological: Ixmyelocel-T | Arm Label: Standard of Care; Type: OTHER; Interventions: Other: Standard of Care | Intervention Type: BIOLOGICAL; Name: Ixmyelocel-T; Assigned to Arm(s): Ixmyelocel-T | Intervention Type: OTHER; Name: Standard of Care; Assigned to Arm(s): Standard of Care
D: Arm Label: Control; Type: SHAM_COMPARATOR; Interventions: Biological: Sham, no injection | Arm Label: C3BS-CQR-1 Treated; Type: EXPERIMENTAL; Interventions: Biological: Injection of C3BS-CQR-1 | Intervention Type: BIOLOGICAL; Name: Injection of C3BS-CQR-1; Assigned to Arm(s): C3BS-CQR-1 Treated | Intervention Type: BIOLOGICAL; Name: Sham, no injection; Assigned to Arm(s): Control

Answer: B