Bioheart is focused on completing the Phase II/III MARVEL study for chronic heart failure using MyoCell. The product candidate has been in clinical trials since May of 2001 with the goal of commercial approval with the current clinical program. There are approximately 130 more patients needed to complete the randomized, double blinded, placebo controlled MARVEL trial. In part one of the MARVEL trial, the performance of MyoCell was nearly 500% above its primary end point goal of 16 meters improvement in exercise capacity testing. MyoCell treated patients improved 91.7 meters while placebo patients declined 4 meters.
MyoCell is a muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the intended purpose of improving cardiac function and quality of life in chronic heart failure patients.
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