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View Full Version : First Trial To Compare Autologous Cells With Donor Cells For Dilated Cardiomyopathy



barbara
02-23-2011, 02:58 PM
Article Date: 22 Feb 2011


Stem cell researchers at the University of Miami Miller School of Medicine's Interdisciplinary Stem Cell Institute are preparing to embark on another research milestone. Joshua M. Hare, M.D., professor of medicine and director of the Interdisciplinary Stem Cell Institute (ISCI), has received approval from the U.S. Food and Drug Administration to begin the first clinical trial in the nation comparing autologous stem cells to donor stem cells for patients with dilated cardiomyopathy, a condition that causes congestive heart failure and is a major cause of death and disability.

Dilated cardiomyopathy directly causes weakness of the heart muscle, a condition that can be very severe and lead to heart failure. It can be caused by viral infections, genetic disorders, inflammation or in many cases the cause is unknown. Patients are treated with medication which can sometimes improve heart function, but some patients' hearts continue to deteriorate and require heart transplantation or other advanced therapies.

ISCI investigators are already studying a number of stem cell types in clinical trials for patients with heart muscle damage from a prior myocardial infarction (heart attack). This new study is the first to examine whether stem cells may also prove beneficial for other forms of heart muscle weakness, and will compare the effects of autologous cells (stem cells derived from a patient's own bone marrow) with allogeneic cells (stem cells from an adult donor). Enrolled patients with dilated cardiomyopathy will be injected with either their own stem cells or cells from a pre-screened healthy donor.

"This trial will answer major questions about the treatment of heart failure, and could transform treatment of these patients," Hare says. "Cell therapy for this condition could reduce the need for heart transplantation and other advanced therapies by providing a viable alternative. Also, using donor cells could make this potential new therapy highly practical and easy to deliver."

While there is quite a bit of excitement about the potential healing ability of stem cells, Hare explains that there is also concern that stem cells taken from a patient who is already ill may be compromised and weakened because of that illness. "This study will help us find out if a heart failure patient's stem cells are already damaged and not as effective. If so, the availability of donor cells could be life-saving to these patients."

The ability to safely and effectively use a donor's cells could also provide physicians with a nearly unending supply of these potentially healing cells. Using autologous cells is a time-consuming process. Physicians must first extract a patient's bone marrow, containing mesenchymal stem cells. Once those mesenchymal cells are separated, they must be cultivated in a lab to enhance their numbers - a process that takes up to six weeks. For some heart failure patients, waiting that long for an effective treatment may not be feasible. "If we can prove that donor cells work as well or better than autologous cells without any negative side effects," says Hare, "that will open up many new doors for us when it comes to new therapies."