Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase I Randomized, Dose Escalation Study of the Safety and Efficacy of Intracoronary Delivery of Cardiosphere-Derived Stem Cells in Patients With Ischemic Left Ventricular Dysfunction and a Recent Myocardial Infarction
Brief Summary: The purpose of this study is to determine whether giving cardiosphere-derived stem cells (CDCs) to patients with decreased heart function and/or a large amount of damaged muscle after a heart attack is safe. CDCs are cells grown from small biopsy samples taken from the heart. Giving a patient their own CDCs is an investigational procedure that has been approved by the Food and Drug Administration for this study. In addition to determining whether this treatment is safe, the study will also examine whether it can decrease the amount of heart muscle damage and/or improve heart function after a heart attack. The amount of heart muscle damage and the function of the heart directly affects prognosis (the predicted course of the disease), and the development of heart failure and other complications some patients experience after a heart attack.

By way of background, scientists and physicians believed, until just a few years ago, that heart muscle damaged after a heart attack could not be replaced. Recently, however, scientists discovered that new heart muscle can form, or be regenerated, and that this process can be enhanced (or increased) by the administration of large numbers of certain cells isolated from the heart or bone marrow. These cells can be stem cells, or cells derived from stem cells, and they may achieve their benefit by forming new heart muscle cells, becoming heart muscle cells themselves, or releasing substances which increase the ability of already existing stem cells to form new heart muscle. All of the studies conducted so far have been experimental and no cell type is approved for routine clinical care of patients with heart disease. However, studies involving bone marrow stem cells do indicate some small improvement in heart function and one large study demonstrated a decrease in clinical events in the group which received bone marrow cells.

Investigators of this study decided to study CDCs because they come from a person's own body, and therefore have no foreign immune antigens which may be rejected. Since the cells come from the person's heart, they are more likely to form heart tissue. In addition, animal studies indicate no safety problems and that these cells are capable of forming heart muscle and blood vessel cells after heart attacks. The investigators are now studying whether the same is true in humans.


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: Mesenchymal stem cell treatment group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mesenchymal stem cell | Arm Label: Control group; Type: PLACEBO_COMPARATOR; Interventions: Drug: Control group | Intervention Type: DRUG; Name: Mesenchymal stem cell; Assigned to Arm(s): Mesenchymal stem cell treatment group | Intervention Type: DRUG; Name: Control group; Assigned to Arm(s): Control group
C: Intervention Type: GENETIC; Name: Intracoronary aotologous stem cell transplantation; Assigned to Arm(s): N/A
D: Arm Label: Cardiac Stem Cell Treatment - Group 1; Type: EXPERIMENTAL; Interventions: Biological: Autologous stem cell infusion | Arm Label: Cardiac Stem Cell Treatment -Group 2; Type: EXPERIMENTAL; Interventions: Biological: Autologous stem cell infusion | Arm Label: Observation (Control Group); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BIOLOGICAL; Name: Autologous stem cell infusion; Assigned to Arm(s): Cardiac Stem Cell Treatment - Group 1 | Intervention Type: BIOLOGICAL; Name: Autologous stem cell infusion; Assigned to Arm(s): Cardiac Stem Cell Treatment -Group 2

Answer: D