While preliminary, the results of the prospective randomized trial indicate that a minimally invasive approach to cell therapy is feasible for the estimated 40 percent of heart failure patients whose disease is unrelated to coronary blockages and who therefore cannot benefit from bypass procedures. Moreover, the experience so far suggests the novel stem-cell approach may be a viable treatment for these and other heart failure patients, reported Dr. Patel, director of clinical cardiac cell therapies at the McGowan Institute.

All 15 of the patients who received stem cell injections had some degree of improvement, some with dramatic results, while the conditions essentially remained unchanged in the 15 randomized to receive injections of their own blood serum.

"It is remarkable the level of improvement we've seen in these patients, who came to us with no other medical or surgical options available to them. However, we don't yet fully understand how these cells work, whether they differentiate to become heart muscle cells or cells that promote vessel growth, or whether they serve as homing signals to other cells and substances that help with repair," explained Dr. Patel.

The study took place at centers in South America. The research team obtained the necessary institutional and government health agency approval and each patient provided informed consent.

All 30 patients enrolled had severe heart failure (New York Heart Association heart failure classifications III and IV) with ejection fraction rates of less than 35 percent. Ejection fraction is a standard measure of heart function and is determined by the total amount of blood that the left ventricle pumps out per heart beat. A patient with good heart function has an ejection fraction of at least 55 percent.

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