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Investigational Bone Marrow Therapy Shows Promise in Treating Damaged Hearts

The U.S. National Heart, Lung and Blood Institute reports that in the United States alone, about 5.8 million people suffer from heart failure. There is no cure, so treatment typically aims to improve quality of life and reduce symptoms including shortness of breath, fatigue and swelling in the ankles, feet, legs and abdomen.

"An increasing number of patients have progressive heart failure due to DCM, even after treatment with drug therapy and surgical intervention," said Dr. Timothy Henry, director of research and an interventional cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital. He was the study's principal investigator. "In this study, patients treated with ixmyelocel-T showed repair in damaged heart muscle and some reversal in heart failure symptoms."

The treatment involves both stem cells and immune cells that are primed to do the job, rather than focusing on one gene or cell type. Ixmyelocel-T was developed by culturing a patient's bone marrow for 12 days to increase the numbers of immune cells, including macrophages and monocytes, as well as mesenchymal cells — stem cells that can differentiate into several different cell types. The resulting treatment was then injected into the patient's heart muscles to encourage growth of new tissue and improve inflammation.

The trial included 22 ischemic (IDCM) and non-ischemic (NIDCM) patients with moderate to severe heart failure. They also had a left ventricular ejection fraction of 30 percent or less, which is a measure of how much blood leaves the heart with each pump. Patients were randomized to receive an injection of the treatment into their heart muscles or to a control group, and were followed at three-, six- and 12-month intervals.

After 12 months, no procedural complications and no difference in adverse events were reported among the patients who received the treatment and the control group. IDCM patients who received the cell treatment had a lower mean number of major adverse clinical events (0.33 compared to 1.67 in the control group) and were more likely to see improvement overall, compared to the other groups.

"Treatment with ixmyelocel-T was well-tolerated, and patients who received the cell therapy showed improved symptoms after one year," Dr. Henry said.

Although the study is preliminary and involved only a small group of patients, its results suggest the treatment is safe and provides a strong basis for a larger clinical trial in DMI patients, he added.

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