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March 18, 2011

Stem cells reverse damage in enlarged hearts in small human trial, will take up to five years for Food and Drug Administration approval

Writing in the journal Circulation Research: Journal of the American Heart Association, scientists show in a small study that stem cell therapy can reverse heart damage in patients with enlarged hearts due to heart attacks. In addition, the benefits from the stem cell injections appear to be three times better than that offered by current medical treatments, according to a release. Scar tissue decreased and heart function improved, the scientists from the University of Miami said.

Over 5 million Americans are burdened now with an enlarged heart due to prior heart attack

The team said the stem cell treatment was well-tolerated with no serious side effects. Hare estimated that the procedure and the cells would cost approximately $10,000 to $15, 000, "not including a hospital fee if one was needed."

The current trial is only a small, run-up phase of extensive testing that will take up to five years and involve dozens of hospitals and hundreds of patients before winning U.S. Food and Drug Administration approval for routine use.

researchers found:

* Heart size decreased an average of 15 percent to 20 percent, which is about three times what is possible with current medical therapies.
* Scar tissue decreased by an average of 18.3 percent.
* And there was dramatic improvement in the function, or contraction, of specific heart areas that were damaged.



University of Miami cardiologists Thursday reported success in a small, preliminary human clinical trial of a new stem cell therapy they hope some day will routinely mend human hearts and reduce the need for lifelong medication, even for transplants.

“That’s the Holy Grail, the quest the whole field has been pursuing for close to a decade, and this is evidence we’re on the right track,” said Dr. Joshua Hare, director of the UM Medical School’s Interdisciplinary Stem Cell Institute

The trial was primarily about the safety of the procedure, and all eight patients came through without significant side effects, he said. The procedure also reduced the size of hearts swollen by previous heart attacks, a condition called cardiomyopathy or simply heart failure.

The reduction was up to 25 percent, while current therapies including medication and pacemakers typically reduce the size by only about 5 percent, he said. The reduction in swelling increases the heart’s ability to pump blood, he said. By implication, it almost certainly improves the patient’s health, although that was not directly measured in the small, early study.

In the study, stem cells were taken from the patient’s own bone marrow and injected by catheter into scar tissue in the patient’s heart caused by an earlier heart attack. It worked in patients such as Eaton, whose heart attack was 11 years ago, Hare said. The hope was that the immature adult stem cells would turn into heart muscle, replacing the scar tissue.

Some of the stem cells did become heart muscle, Hare said; they also triggered the heart to produce more of its own stem cells which became new heart muscle as well, he said.

The next step is two more near-term studies. The first, which started in 2009, is a double-blind, placebo-controlled study of 60 patients designed further to test the safety of the procedure, but primarily its efficacy, or how well it works.

Another study about to get underway will see whether bone marrow from a donor can work as well as the patient’s own bone marrow.

Later, researchers will conduct a study involving 50 to 100 hospitals and many hundreds of patients aimed at winning final FDA approval.


Intramyocardial Stem Cell Injection in Patients With Ischemic Cardiomyopathy

Conclusions:These data suggest that transcatheter, intramyocardial injections of autologous bone marrow progenitor cells improve regional contractility of a chronic myocardial scar, and these changes predict subsequent reverse remodeling. The findings support the potential clinical benefits of this new treatment strategy and ongoing randomized clinical trials.

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