Allina Health physician says treatment with ixmyelocel-T improves outcomes
in heart failure patients
MINNEAPOLIS 05/11/2012--An investigational therapy derived from a patient’s own bone marrow stem cells improves heart function in some patients with progressive heart failure due to dilated cardiomyopathy (DCM), according to the results of a Phase 2a study presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions 2012 Scientific Sessions in Las Vegas.
Ixmyelocel-T is 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 cell treatment is then injected into the patient's heart muscles to encourage growth of new tissue and improve inflammation.
"An increasing number of patients have progressive heart failure due to dilated cardiomyopathy, even after treatment with drug therapy and surgical intervention," said Timothy Henry, MD, FSCAI, director of research and an interventional cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital, and 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 trial included 22 ischemic (IDCM) and non-ischemic (NIDCM) patients with a New York Heart Association (NYHA) heart failure class of III or IV, or moderate to severe heart failure, and 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 3, 6 and 12 months.
After 12 months, no procedural complications and no difference in adverse events were reported among 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). IDCM patients who received the treatment were more likely to see improvement in NYHA class, six-minute walking distance and ejection fraction, compared to NIDCM patients who received the treatment and those in the control group.
"Treatment with ixmyelocel-T was well-tolerated and patients who received the cell therapy showed improved symptoms after one year," said Dr. Henry. "The results provide a strong basis for a larger clinical trial of this treatment in patients with dilated cardiomyopathy."
The study was sponsored by Aastrom Biosciences.
Dr. Henry presented "Safety and Efficacy of Ixmyelocel-T, An Expanded Patient-Specific Mixed Cell Therapy, in Dilated Cardiomyopathy" on Thursday, May 10, 2012.
About Minneapolis Heart Institute and Allina Health
Minneapolis Heart Institute, part of Allina Health, is recognized internationally as one of the world’s leading providers of heart and vascular care. This state-of-the-art facility combines the finest in personalized patient care with sophisticated technology in a unique, family-oriented environment. The Institute's programs, a number of which are conducted in conjunction with Abbott Northwestern Hospital, address the full range of heart and vascular health needs: prevention, diagnosis, treatment and rehabilitation.
Allina Health is dedicated to the prevention and treatment of illness and enhancing the greater health of individuals, families and communities throughout Minnesota and western Wisconsin. A not-for-profit health care system, Allina Health cares for patients from beginning to end-of-life through its 90+ clinics, 11 hospitals, 15 pharmacies, specialty care centers and specialty medical services that provide hospice care, oxygen and home medical equipment, and emergency medical transportation services.
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