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Stem cell treatment of damaged hearts
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Encouraging results have been obtained from Part 1 of an an ongoing clinical study for stem cell treatment of damaged hearts. The trial, termed MARVEL, is sponsored by Bioheart Inc., a small biotechnology company. 
The MARVEL Clinical Program is designed to assess function and quality of life in patients with advanced congestive heart failure (CHF), after receiving injections of adult muscle stem cell therapy in their damaged heart muscle. CHF is a debilitating and common disease in which the heart’s ability to pump blood is impaired. The American Heart Association estimates there are over 5 million heart failure patients in the United States, with direct and indirect costs exceeding $30 billion.
Stem cells are immature cells that have the ability to develop into specialized functions such as heart muscle, and therefore have tremendous clinical potential for treating intractable diseases. However, the ethical considerations of deriving stem cells from embryonic tissue have triggered extensive research in isolating adult stem cells from adult tissues.
The MARVEL trial uses adult stem cells derived from the patient’s own leg muscles. Patient biopsy samples were shipped to Bioheart, where myoblasts or muscle stem cells were isolated and expanded to a sufficient number to inject back into the patient. Over the six-month observation period, the patients treated with stem cells increased their walking distance by 91 meters, while placebo-treated patients decreased their walking distance by 4 meters. No significant stem cell related safety concerns were observed.
These results of MARVEL Part 1 suggest that certain patients with heart failure could return to a more active lifestyle following treatment with stem cells. However promising, it must be stressed that MARVEL is a small pilot study based on analyses of 3- and 6- month follow-up data from 20 patients. Therefore the results must not be overstated. Nevertheless, the pronounced improvement in walking distance has the investigators eager to move on to the next stage of the MARVEL trial.
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