Title: Transplantation in Myocardial Infarction Evaluation (TIME) Protocol: A Phase II, Randomized, Controlled, Double-Blind Trial Evaluating the Effect of Timing on the Administration of Bone Marrow Mononuclear Cells (BMMNCs) versus Placebo in Patients with Acute Myocardial Infarction

Purpose: Myocardial infarction (heart attack) results from a blood clot forming in one of the coronary arteries. This blood clot blocks the flow of blood into the heart resulting in injury and death to some of the heart muscle. Treatment involves a procedure called angioplasty which opens up the blocked artery and restores blood flow to the heart muscle. However, if severe enough, some form of permanent (lasting) heart damage can result. There may be a significant amount of heart tissue that has been injured that may not recover. In some cases, this injury may result in enlargement of the heart and may lead to a condition called congestive heart failure.

Bone marrow contains special stem cells that may promote blood vessel growth, prevent cell death, and transform themselves into a number of tissues including muscle. Recent studies in animals and humans have shown that these stem cells can improve heart muscle function following a heart attack.

The purpose of this study is to determine if these cells taken from an individual’s bone marrow can be transplanted back into the injured heart muscle of the individual and improve the heart’s function following a heart attack. Additionally, because this study is transplanting these cells either 3 days or 7 days following a heart attack, it will help determine the best time for transplant of these cells following such an event.

Enrollment: 120 individuals will be enrolled at the five clinical centers and will be followed for up to 24 months.

Title: Late-TIME Protocol: A Phase II, Randomized, Controlled, Double-Blind Pilot Trial Evaluating the Safety and Effect of Administration of Bone Marrow Mononuclear Cells Two to Three Weeks Following Acute Myocardial Infarction.

Purpose: This pilot study is an extension of Study 1: TIME. The purpose of this study is to determine if cells taken from an individual’s bone marrow can be transplanted back into the injured heart muscle of the individual and improve the heart’s function following a heart attack. Additionally, because this study is transplanting these cells two to three weeks following a heart attack, it will help determine the best time for transplant of these cells following such an event.

Enrollment: 87 individuals will be enrolled at the five clinical centers and will be followed for up to 24 months.

Title: FOCUS Protocol: A Randomized, Controlled, Phase II, Double-Blind Trial of Intramyocardial Injection of Autologous Bone Marrow Mononuclear Cells under Electromechanical Guidance for Patients with Chronic Ischemic Heart Disease and Left Ventricular Dysfunction.

Purpose: A diagnosis of coronary artery disease means there are blockages in the blood vessels that supply the heart. This is many times accompanied by left ventricular dysfunction; meaning the heart does not pump blood as well as it should. When these two conditions combine, it is called congestive heart failure. Due to this weakened condition of the heart, arteries are not always suitable for coronary artery bypass surgery or stenting.

Recent studies are investigating whether bone marrow cells are injected into the heart muscle are able to promote blood vessel growth that will improve the blood supply to the heart and the heart’s ability to pump blood. A small number of these procedures have been done in other countries and one study is currently being conducted in the United States.

The purpose of this study is to determine the safety and effectiveness of this technique in people who are not ideal candidates for other forms of standard therapy such as surgery or use of standard catheter-based techniques such as balloon angioplasty or stent placement.

Enrollment: 87 individuals will be enrolled at the five clinical centers and will be followed for up to 60 months.