Devices & Diagnostics

Arteriocyte gets FDA approval to begin critical limb ischemia clinical trial

Stem cell developer Arteriocyte has received approval from the U.S. Food and Drug Administration to begin a clinical trial for the treatment of critical limb ischemia.

Stem cell developer Arteriocyte has received approval from the U.S. Food and Drug Administration to begin a Phase 1 clinical trial for the treatment of critical limb ischemia.

The trial will investigate the use of Arteriocyte’s Magellan technology to improve blood flow in patients suffering from critical limb ischemia (CLI), a severe obstruction of the arteries that reduces blood flow to hands, feet or legs, according to a statement from Cleveland-based Arteriocyte. Serious cases can lead to amputation.

The company’s Magellan device  harvests and quickly concentrates stem cells and blood platelets during surgeries. These concentrated cells can be injected into patients, boosting the body’s ability to repair itself. The device is used in about 6,000 surgeries per month, according to the company.

In addition to CLI, Arteriocyte plans to begin clinical trials assessing Magellan’s ability to treat cardiovascular disease, and the clinical setting of orthopedics and tissue repair during 2011, according to the statement.

The Phase 1 CLI trial will begin enrolling patients immediately at Ohio State University Medical Center.

Arteriocyte CEO Don Brown discussed the company’s Magellan technology during a November interview with MedCity News.

“The synergy that the Magellan technology brings to our core efforts is a device that enables rapid bedside processing of tissue — blood or bone marrow — that delivers back to the surgeon a concentrated injectate of those cells for use as the surgeon deems appropriate,” Brown said.

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