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United States FDA Clears the REGEN Trial to Test Bioheart's Combination Gene and Stem Cell Therapy in Heart Failure Patients
Date:7/28/2009

SUNRISE, Fla., July 28 /PRNewswire-FirstCall/ -- 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).

MyoCell SDF-1 is a composition of myogenic stem cells derived from a patient's own thigh muscle that has been modified to over express the SDF-1 protein. The product candidate is prepared with an 18-step proprietary method in a cGMP laboratory. Utilizing a needle-tipped catheter inserted into the groin of a patient who is suffering from heart failure, the cells are injected into the scar tissue that has formed in the patient's heart. The goal of MyoCell SDF-1 is to grow new contractile muscle within the scar tissue that will have the ability to release additional beneficial proteins to assist in the tissue repair process and improve the patient's heart function, exercise capacity and quality of life. In preclinical studies, MyoCell SDF-1 provided a 54 percent improvement of heart function compared to 27 percent for the original MyoCell composition while the placebo control treated animals declined by 10 percent. The preclinical studies also demonstrated that this product candidate can enhance blood vessel formation in damaged hearts.

"We are happy to be able to begin the REGEN trial to test this promising product candidate in heart failure patients after completing very successful preclinical testing," said Howard Leonhardt, Bioheart's Chairman and CEO. "To our knowle
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SOURCE Bioheart, Inc.
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