Spectrum participating in PAD clinical trial

September 2, 2011
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Spectrum Health is taking part in a clinical trial designed to evaluate the use of a patient’s own stem cells to prevent leg amputations and improve circulation for those who suffer from end-stage peripheral arterial disease, also known as PAD.

The trial’s sponsor is Biomet Biologics, a designer of biotechnology products with corporate headquarters in Warsaw, Ind. Biomet developed a new investigational treatment strategy to improve blood flow called the MarrowStim PAD Kit, which reportedly enhances the body’s own ability to grow new blood vessels. That process is called angiogenesis. It involves extracting stem cells from bone marrow and then injecting the cells on multiple occasions into the legs.

Spectrum Health will be one of 20 U.S. sites in the trial, which will test the safety and effectiveness of the MarrowStim PAD Kit on 152 volunteers. Patients will be randomly selected to receive the Biomet product or a placebo and will be observed and evaluated for a year. Roughly 8 million Americans suffer from a serious version of PAD, which occurs when cholesterol and fat collect on arterial walls to create blood blockages and increase the risk for strokes and heart attacks.

“Most patients with PAD can be treated with lifestyle changes, medicines and endovascular or surgical procedures,” said Christopher Chambers, a vascular surgeon with the Spectrum Health Medical Group, in a statement.

“However, despite advanced techniques and technology, about 10 to 20 percent of people with severe PAD do not respond to these measures and are at risk for lower limb major amputation. I’m hoping this new investigational technology will give those patients another option,” said Chambers.

Standard treatments, such as surgical bypass and angioplasty, often do not improve blood flow in the severest of PAD cases, and that makes amputation the only medical alternative. The U.S. Food and Drug Administration has approved the clinical test. Spectrum Health is recruiting West Michigan patients for the trial.

Spectrum Health is the region’s largest medical provider and largest employer with 17,800 employees. Greater Michigan Biomet, a division of Biomet Biologics, is located at 6641 S. Division Ave. in Byron Center.

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