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Article Excerpt
* The MARVEL Clinical Program is designed to assess functional capacity and quality of life in patients with advanced heart failure after receiving injection of adult muscle stem cell therapy in their damaged heart muscle
* The MARVEL Phase II/III clinical trials are set to become a global benchmark study in CHF leading
* The 6 minute walk distance (6MWD, an established parameter of efficacy utilized in heart failure studies), one of the primary end points of MARVEL Part 1, increased on average by more than 91 meters in cell-treated patients, whereas in the placebo-treated group a decrease of nearly 4 meters was seen
* No significant stem cell related safety concerns
SUNRISE, Fla. -- Bioheart, Inc. (OTCBB:BHRT), presented positive efficacy data from part 1 of its Phase II/III clinical trial at the Heart Failure Society of America (HFSA) Meeting in Boston, Massachusetts. Thomas Povsic, MD, Ph.D., Assistant Professor of Medicine at Duke University, presented the final data for Part 1 of the MARVEL Phase II/III Clinical Trial as a part of the Late Breaking Clinical Trials Session. Along with Dr. Povsic, Chris O'Connor, MD, Head of Heart Failure at Duke University and the study's Principal Investigator Warren Sherman, MD, Director of Stem Cell Research and Regenerative Medicine at the Center for Interventional Vascular Therapy of Columbia University Medical Center, attended the presentation and fielded questions regarding the scientific and clinical implications of MARVEL Part 1.
In furthering its near-term goal of providing positive "pivotal data" of autologous skeletal myoblasts (ASM, or MyoCell[R], Bioheart's flagship biologic product), the MARVEL Program applies study designs that emphasize double-blind, placebo control strategies. Dr. Povsic's presentation centered upon data from MARVEL Part 1, the first study of its kind to utilize catheter-based cell delivery in a double-blinded, placebo-controlled manner.
Patients in MARVEL Part 1, all of whom...
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