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Stem Cell Trial Offers Hope for Patients with Severe Ischemic Heart Disease

BOSTON - February 26, 2008 - Patients with ischemic heart disease, a serious condition that occurs when the heart's arteries become clogged with cholesterol plaque, may have new options if they have exhausted traditional cardiovascular therapies. A clinical trial at the Massachusetts General Hospital (MGH) Heart Center is using patients' own stem cells to improve circulation in hearts damaged by inadequate blood flow, by promoting the growth of new, microscopic blood vessels.

The clinical trial, called the Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) trial, is aimed at patients who continue to experience severe chest pain and have failed conventional therapies with medication, angioplasty and stenting, and bypass surgery.

Douglas Drachman, MD, an interventional cardiologist at the MGH Heart Center and the lead investigator along with Kenneth Rosenfield, MD, describes the stem cell therapy as a very promising technique that may encourage growth of new blood vessels on the heart, thereby improving blood flow to the vital heart muscle. Better circulation allows more blood and oxygen to reach the heart, reducing chest pain, also known as angina.

"Stem cell therapy in the ACT-34 CMI trial could offer an important new opportunity for patients who otherwise might have no options - patients who have lifestyle-altering or disabling angina," says Drachman. "This is a new type of therapy that may offer the possibility of real benefit when all conventional treatments - with medication, angioplasty and stenting, and bypass surgery - have failed or are no longer an option."

During this trial, each patient's natural production of stem cells is enhanced through a series of injections of growth factors. The stem cells are then harvested from the bloodstream through a technique called apheresis. Using "NOGA" mapping - a sophisticated catheter-based imaging system that allows physicians to construct and navigate through a three-dimensional image of the heart - the research team determines the exact location in the heart's muscle where improved blood flow is most needed. The catheter system is then used to inject the cells directly into the heart muscle at these sites, with the hope that the cells will stimulate the growth of new blood vessels.

Massachusetts General Hospital is the only site in New England participating in the multi-center ACT-34 CMI trial. Drachman and his colleagues are actively engaged in bringing several other stem cell trials to Mass General in the following year in an effort to improve treatments not only for patients with ischemic heart disease, but also for patients with a variety of other conditions ranging from advanced congestive heart failure to critically reduced circulation in the legs.

Ischemic heart disease, also called coronary artery disease or coronary heart disease, is a leading health problem in the United States. According to Circulation, the journal of the American Heart Association, coronary heart disease caused one out of every five deaths in the United States in 2004. In 2008, it is estimated that 770,000 Americans will have a new coronary attack and about 430,000 will have a recurrent attack.
When the coronary arteries leading to the heart become blocked due to build-up cholesterol plaque and blood clots, the blood flow and oxygen supply to the heart muscle is impaired. The resulting ischemic heart disease is a major cause of severe chest pain, heart attacks, and sudden death.

Founded in 1811, the MGH is the third oldest general hospital in the United States and the oldest and largest in New England. The 900-bed medical center offers sophisticated diagnostic and therapeutic care in virtually every specialty and subspecialty of medicine and surgery. Each year the MGH admits more than 46,000 inpatients and handles nearly 1.5 million outpatient visits at its main campus and health centers. Its Emergency Department records nearly 80,000 visits annually. The surgical staff performs more than 35,000 operations and the MGH Vincent Obstetrics Service delivers more than 3,500 babies each year. The MGH conducts the largest hospital-based research program in the country, with an annual research budget of more than $500 million. It is the oldest and largest teaching hospital of Harvard Medical School, where nearly all MGH staff physicians serve on the faculty. The MGH is consistently ranked among the nation's top hospitals by US News and World Report.

Media Contact: Jennifer Gundersen, MGH Public Affairs

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