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: 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
B: Intervention Type: PROCEDURE; Name: Intramyocardial injection of autologous CD133+ marrow cells; Assigned to Arm(s): N/A
C: Arm Label: Peripheral; Type: EXPERIMENTAL; Interventions: Drug: Granulocyte-colony stimulating factor | Arm Label: Percutaneous intracoronary injection; Type: EXPERIMENTAL; Interventions: Drug: Granulocyte-colony stimulating factor, Procedure: Percutaneous intracoronary injection | Arm Label: Percutaneous intramyocardial injection; Type: EXPERIMENTAL; Interventions: Drug: Granulocyte-colony stimulating factor, Procedure: Percutaneous intramyocardial injection | Intervention Type: DRUG; Name: Granulocyte-colony stimulating factor; Assigned to Arm(s): Percutaneous intracoronary injection, Percutaneous intramyocardial injection, Peripheral | Intervention Type: PROCEDURE; Name: Percutaneous intracoronary injection; Assigned to Arm(s): Percutaneous intracoronary injection | Intervention Type: PROCEDURE; Name: Percutaneous intramyocardial injection; Assigned to Arm(s): Percutaneous intramyocardial injection
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Biological: Autologous human mesenchymal cells (hMSCs) | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Biological: Autologous human bone marrow cells (hBMCs) | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: Autologous human mesenchymal cells (hMSCs); Assigned to Arm(s): 1 | Intervention Type: BIOLOGICAL; Name: Autologous human bone marrow cells (hBMCs); Assigned to Arm(s): 2 | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): 3

Answer: A