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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