MyoCell(R) Clinical Therapy is currently being investigated in MARVEL(1), a randomized, double-blind, placebo-controlled, multi-center Phase II/III Trial involving 330 patients. The largest trial of its kind to date, MARVEL is currently enrolling NYHA Class II-IV congestive heart failure patients in approximately 25 of the most important cell therapy centers in the U.S. In the MARVEL Trial, MyoCell(R) is being delivered via a MyoStar(TM) injection catheter(2), in combination with the NOGA(R) XP Cardiac Navigation System. The Principal Investigator for the MARVEL Trial is Warren Sherman, MD, Director, Cardiac Cell-based Endovascular Therapies, Columbia University Medical Center, New York.
"We are very proud of our continued progress with our MyoCell(R) Clinical Therapy and our pre-clinical work with SDF-1," said Howard J. Leonhardt, Bioheart CEO and Chief Technology Officer. "We are currently working with the FDA on obtaining an IND approval for the start of our human trial involving SDF-1."
ABOUT CONGESTIVE HEART FAILURE
Congestive heart failure (CHF), or heart failure, is a condition in which the heart cannot pump enough oxygenated blood to the body's vital organs. People with heart failure find that they cannot exert themselves as they become tired and short of breath. Current therapeutic options include palliative medical therapy (symptom-treating medicine), cardiac assist devices or cardiac transplantation. Heart failure is a leading cause of hospitalizations in people over age 65.
ABOUT MYOCELL(R) CLINICAL CELL THERAPY
MyoCell(R) clinical cell therapy, developed by Bioheart, Inc., is
currently being studied as an investigational product in Europe and the
U.S. MyoCell(R) clinical cell therapy is intended to be used to improve
cardiac function months or even years after a patient has suffered severe
heart damage due to a heart attack. The procedure involves a physician
removing a small amount of muscle obtained from
|SOURCE Bioheart, Inc.|
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