Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effects of Autologous Intracoronary Stem Cell Transplantation In Patients With End-Stage Dilated Cardiomyopathy
Brief Summary: Several studies have documented that transplantation of bone marrow-derived cells (BMC) following acute myocardial infarction is associated with a reduction in infarct scar size and improvements in left ventricular function and perfusion. The available evidence in humans suggests that BMC transplantation is associated with improvements in physiologic and anatomic parameters in both acute myocardial infarction and chronic ischemic heart disease, above and beyond the conventional therapy. In particular, intracoronary application of BMC is proved to be safe and was associated with significant improvement in the left ventricular ejection fraction (LVEF) in patients with chronic heart failure.

In contrast to ischemic heart failure, the data on effects of BMC transplantation in patients with dilated cardiomyopathy are limited to pre-clinical studies. In a rat model of dilated cardiomyopathy, intramyocardial delivery of pluripotent mesenchymal cells improved LVEF, possibly through induction of myogenesis and angiogenesis, as well as by inhibition of myocardial fibrosis, suggesting that the beneficial effects of stem cell transplantation in dilated cardiomyopathy may primarily be related to their ability to supply large amounts of angiogenic, antiapoptotic, and mitogenic factors. Similarly, transplantation of cocultured mesenchymal stem cells and skeletal myoblasts was shown to improve LVEF in a murine model of Chagas disease.

Study Aim:

To define the clinical effects of BMC transplantation in dilated cardiomyopathy in a pilot clinical study investigating the effects of intracoronary CD34+ cell transplantation on functional, structural, neurohormonal, and electrophysiologic parameters in patients with end-stage dilated cardiomyopathy.


Options:
A: Arm Label: SC Group; Type: EXPERIMENTAL; Interventions: Biological: CD34+ autologous stem cell transplantation, Drug: Bone Marrow Stimulation, Biological: SC therapy | Arm Label: Controls; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BIOLOGICAL; Name: CD34+ autologous stem cell transplantation; Assigned to Arm(s): SC Group | Intervention Type: DRUG; Name: Bone Marrow Stimulation; Assigned to Arm(s): SC Group | Intervention Type: BIOLOGICAL; Name: SC therapy; Assigned to Arm(s): SC Group
B: Arm Label: Autologous hMSCs; Type: ACTIVE_COMPARATOR; Interventions: Biological: Autologous hMSCs | Arm Label: Allogeneic hMSCs; Type: ACTIVE_COMPARATOR; Interventions: Biological: Allogeneic hMSCs | Intervention Type: BIOLOGICAL; Name: Autologous hMSCs; Assigned to Arm(s): Autologous hMSCs | Intervention Type: BIOLOGICAL; Name: Allogeneic hMSCs; Assigned to Arm(s): Allogeneic hMSCs
C: 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
D: Intervention Type: PROCEDURE; Name: Intramyocardial injection of autologous bone marrow cells; Assigned to Arm(s): N/A

Answer: A