"To our knowledge, this will be the first clinical trial ever to test a combination gene and stem cell therapy for cardiovascular disease."

— Howard Leonhardt, Bioheart chairman/CEO, on his company's 15-patient REGEN trial, a study designed to assess the safety and cardiovascular effects of the implantation of MyoCell SDF-1 in CHF patients post myocardial infarction, "FDA approves first stem cell-gene therapy study for CHF."