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Venous Leg Ulcers

Advanced BioHealing initiates Celaderm clinical trial for leg ulcers

Published in Medical Letter on the CDC and FDA, December 17th, 2006

Advanced BioHealing, Inc., (ABH) has received conditional clearance from the United States Food and Drug Administration (FDA) to begin enrolling patients in a pilot trial of Celaderm, the company's next generation bioengineered tissue product.

The study, whose primary purpose is to evaluate the safety of Celaderm in humans, is expected to enroll 55 patients at six clinical sites in the United States and will also assess the potential for Celaderm to accelerate healing of venous leg ulcers.

"We are delighted to begin working with some of the world's leading investigators on the clinical development of this exciting new product," said David Eisenbud,...

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