Bioheart Announces Plans to Advance LVAD + Muscle Stem Cells Clinical Trial

Wed, 12/08/2010 - 3:37pm

SUNRISE, Fla., Dec. 8, 2010 /PRNewswire-FirstCall/ -- Bioheart, Inc. (OTC Bulletin Board: BHRT) announced today that at the American Heart Association Annual Meeting, it finalized the formation of a working group. The group's focus is to advance a BRIDGE TO RECOVERY clinical trial, combining a left ventricle assist device (LVAD) and Bioheart's MyoCell adult muscle stem cell composition and Bioheart's MyoCath needle tipped catheter delivery system.   Initial participants in developing this proposed protocol design include:Dr. Frank Pagani, University of MichiganDr. Warren Sherman, Columbia UniversityDr. Ernst Schwarz, Ceders Sinai UCLADr. Nabil Dib, University of California San Diego and Mercy Gilbert Hospital PhoenixDr. Carl Pepine, University of Florida Shands HospitalDr. Doris Taylor, University of MinnesotaThe expected study design pending potential modification will include 3 treatment arms: Group 1 - Patients receive MyoCell SDF-1 single dose via MyoCath catheter delivery after LVAD placement.Group 2 - Patients receive MyoCell in multiple injection sessions over 6 months via MyoCath catheter delivery following LVAD placement.Group 3 - Patients receive LVAD only. The end points in the trial will include exercise capacity, functional improvements and success in weaning off the LVAD."At the AHA meeting, improvements in survival of heart failure patients were reported from trials with battery powered pacers and mechanical left ventricle assist heart pumps.  These devices help patients cope with their failing heart, but do little to repair damaged scar tissue in the heart, which is often the primary source of heart failure.  The MyoCell composition from Bioheart has demonstrated an ability to grow new contractile muscle in scar tissue and thus, may actually address the underlying problem.  Supporting the patient with an LVAD temporarily during the time period




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