Stem Cell Study Seeks to Prevent Congestive Heart Failure
Researchers at the Minneapolis Heart Institute Foundation have launched a study to examine whether administration of stem cells to first time heart attack patients can prevent the development of congestive heart failure (CHF).
CHF diagnosis is the leading cause of hospitalization in the United States and is responsible for more than 50,000 deaths a year. Currently, heart transplantation is the only available cure.
Each year more than one million Americans have their first heart attack, putting them at risk of developing CHF as a result of cardiac cell death and scar formation which results in diminished pumping ability of the heart and leads to exercise intolerance and fluid retention. However, researchers believe that patients' own bone marrow-derived stem cells, which are capable of secreting a variety of growth and survival factors, can improve cardiac function after a heart attack and fend off the development of CHF.
To date, several clinical trials in Europe have demonstrated the safety and feasibility of using adult stem cells for cardiac repair following acute myocardial infarction, but in most of the studies the heart attacks were small and unlikely to lead to the development of CHF. The Minneapolis Heart Institute Foundation study is being done in conjunction with the University of Minnesota and is intended to look exclusively at patients with moderate to large heart attacks, putting them at risk of developing CHF.
"The Minneapolis Heart Institute Foundation is dedicated to exploring new treatments for heart disease, and stem cells may be the next frontier in therapy," said Jay Traverse, MD, a cardiologist with the Minneapolis Heart Institute and principal investigator for the study. "If we can prove that using adult stem cells can reduce the development of CHF, many people could potentially benefit from this study."
This first-of-its-kind study in the United States is randomized and placebo-controlled, involving 60 patients with moderate to large anterior infarctions who will receive an intra-coronary infusion of their own stem cells or placebo. All patients will receive standard treatment including aspirin, beta-blockers, ACE inhibitors and statins.
Patients with acute myocardial infarctions will be admitted to the University of Minnesota or to Abbott Northwestern Hospital through its nationally recognized Level 1 Heart Attack Program, which allows patients to undergo immediate angioplasty and stenting. Patients will then undergo bone marrow aspiration and harvesting of their stem cells three to seven days later, which will be followed by an intra-coronary infusion of the isolated stem cells on the same day. Of the 60 patients in the study, 45 patients will have their stem cells infused through a catheter in the region of their heart attack and 15 will receive a placebo (in an effort to examine whether late administration of stem cells is effective for repairing damaged heart muscle, patients in the placebo group will receive cell therapy six months following their heart attack).
This study, which is funded by the Minneapolis Heart Institute Foundation, the Abbott Northwestern Hospital Foundation and the National Institutes of Health, is being conducted following approval from the U.S. Food and Drug Administration in September 2005. Traverse and his colleagues at the Minneapolis Heart Institute and the University of Minnesota will monitor patients for two years following stem cell treatment to determine whether stem cell therapy reduces scarring and improves cardiac function as determined by cardiac MRI.
The Minneapolis Heart Institute Foundation is a non-profit organization dedicated to improving heart health through meaningful advancements in research and education. For additional information about MHIF, please visit our website at
www.mplsheartfoundation.org.
