PLYMOUTH, Mass., April 20, 2011 /PRNewswire/ -- Harvest Technologies Corp. (www.harvesttech.com) announced today that the first twelve patients of its sixty patient Heart Failure trial have been enrolled at Medanta-the Medicity in Gurgaon INDIA.
The trial is intended to evaluate the safety and clinical effect of Harvest's BMAC autologous cell composition to treat patients with Congestive Heart Failure (CHF) when using a minimally invasive retrograde coronary sinus delivery. This is a randomized, controlled design treating both ischemic and non-ischemic heart failure patients. Patient enrollment will take place in sites in India, Germany and Peru and will feature electronic data entry with its data coordinating center at the University of Utah. The overall trial will be directed by Amit Patel, MD, Director, Center for Cardiac Cell Therapy at the University of Utah. The trial is being conducted in compliance with the United States FDA clinical trial regulations, ICH GCP, local IRB or IEC regulations and the "Declaration of Helsinki" and a Data Safety Monitoring Board (DSMB) will monitor adverse events.
Congestive Heart Failure is a persistent and relentless problem, which affects over an estimated 20 million patients world-wide. It occurs when the heart's ability to pump blood is so impaired that "systemic perfusion is inadequate to meet the body's demands" and this condition cannot be mediated by either by medication or surgical or endovascular intervention. A major advance in treatment is needed which could reverse this condition and in ischemic patients initiate neovascularization to restore perfusion within the affected area of the myocardium.
While there are several cardiac trials that have shown a clinical effect arising from the delivery of bone marrow cells through the coronaries, this approach offers several advantages according to Dr. Patel. "This novel delivery approach has several advantages over the antigrade approach. It is a safer approach into the heart, allows for the delivery of significantly more cells and in our experience results in substantially greater cell retention. In addition, the Harvest rapid processing of bone marrow in the procedure room could allow the procedure to be done on an outpatient basis."
"Congestive Heart Failure is a cruel, debilitating disease effecting over 20 million people. Although many of the cell therapy studies have demonstrated promise, the improvements shown have been less than ideal. We are extremely optimistic that this study will show the improvement in clinical results that can eventually lead to a treatment option for this patient population," states Gary Tureski, President Harvest Technologies.
Harvest Technologies is a privately held company based in Plymouth, Mass.
P. Kevin Benoit; VP / General Manager Strategic Business Development – 508-732-7500
|SOURCE Harvest Technologies Corp.|
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