Bioheart, Inc., (OTC Bulletin Board: BHRT) a company committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases announced today that the US FDA cleared a phase I clinical trial for MyoCell SDF-1 (Stromal Derived Factor - 1) to treat congestive heart failure. The REGEN trial will enroll 15 patients in a multicenter, randomized, dose escalation study to assess the safety and cardiovascular effects of the implantation of MyoCell SDF-1 in congestive heart failure patients post myocardial infarction(s).