Rejuvenating Heart Tissue (9/6/2006)
Phase one clinical trials for a proceedure to rejuvenate damaged heart tissue have begun.
20 patients in groups of 5 have been accepted into the phase one clinical trials that intend to
regenerate damaged heart tissue using tissue regeneration therapy. The selected patients are all
suffering from previous myocardial infarction(s) involving the anterior, lateral, posterior or inferior walls
of the heart. The study is slated to last until mid-2007.
The procedure starts by taking a biopsy of approximately 5-10 grams of skeletal muscle from the subject’s leg muscle.
The sample is then isolated and grown in vitro using MyoCell™ at an offsite cGMP (Current Good Manufacturing Practices) culture laboratory. Once expanded,
the myoblast cells will be implanted onto the scarred region of the heart using a device called the MyoCath™ transendocardial delivery catheter system.
The study is sponsored by Bioheart Inc, located in Sunrise Florida. Bioheart has been developing cell-based
therapy products for cardiovascular diseases since June of 1999. They hold over 14 patents and patents pending related
to the cell treatment of a failing heart, including a biologic pacemaker called BioPace.
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