Medical Device Daily

Nearly 5 million people in the U.S. are plagued with congestive heart failure, and trends seem to indicate that the incidence of this deadly disease hasn't declined in the last 20 years. While the number of those suffering with the disease continues to grow at a rate of 550,000 annually, it is estimated that the healthcare cost for these patients exceeds $29 billion a year.

Heart failure results from the progressive deterioration of the pumping function of the heart, leading to its inability to pump sufficient blood to the body's tissues, organs and limbs. The majority of heart failure patients have underlying cardiovascular disorders that are often the precursors of their condition. The most common of these are atherosclerosis, myocardial infarction, hypertension, cardiomyopathy and arrhythmia.

Enter Angioblast Systems (New York), a private company looking at what it calls a novel approach at stemming the tide of cardiovascular disease. The company plans to use allogenic stem cells to treat congestive heart failure – allogenic cells meaning those cells that are obtained from unrelated, universal donors and are classified as off-the shelf, mesenchymal precursor cells.

Stem cells are commonly referred to as "generic" cells that can regenerate themselves and develop into specialized cells, such as cardiac cells. In stem cell therapy, the stem cells are typically removed from another part of the patient's body — usually the bone marrow or the blood, both of which contain a variety of stem cell types. The cells are then transplanted into the heart, where they can lead to the growth of new heart muscle and blood vessels to replace damaged tissues.

Last week Angioblast reported at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington safety data from the first seven patients enrolled in the trial, who underwent its Revascor MPC Cell Therapy process.

There were no adverse events according to Nabil Dib, MD, director of cardiovascular research for Chandler Regional and Mercy Gilbert medical centers in Arizona.

"We hope that the stem cells will increase the potential for myocardial repair and restoration of heart function, Angioblast's Revascor cells are a well characterized, pure population of MPCs, Dib said. "These cells, obtained from a healthy young adult donor are isolated, expanded and cultured to produce treatments for potentially thousands of patients."

Here's how the therapy works.

Angioblast's Revascor adult stem cells are delivered to damaged areas of the heart by a minimally invasive cardiac catheterization procedure performed under local anesthesia while the patient is awake. Patients undergoing the procedure are released from the hospital within 24 hours.

The placebo-controlled trial of Angioblast's Revascor MPC cell therapy will randomize up to 60 patients suffering from congestive heart failure, including those with non-ischemic cardiomyopathy, to either implantation with allogeneic adult stem cells or standard of care in a 3:1 ratio.

"I think it's safe to say that within the next five years, the we want to be able to bring this to market," Michael Schuster, VP of operations for Angioblast, told Medical Device Daily. "We've been working with the FDA and the guidance that we've received is that we need a rigorous manufacturing process so not every center can replicate this."

The company first received FDA approval to launch the stem cell trial a little more than a year ago (MDD, May 7, 2007). The trial is using catheters provided by Angioblast's partners, Cordis (Miami Lakes, Florida) and Biosense Webster (Diamond Bar, California).

Mesoblast and Angioblast also are conducting a pilot clinical trial in Australia using autologous cells as therapy for coronary artery disease (MDD, Sept. 26, 2006).

"We've received positive feedback the consensus in the scientific community is that this is a safe procedure," Schuster said.

Angioblast develops treatments for cardiac, vascular and eye conditions. Its lead products are based on commercialization of an adult stem cell technology capable of regulating blood vessel growth critical for the treatment of ischemic heart disease and macular degeneration/diabetic eye disease.

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