FDA approves US trial of Celution System

The US Food and Drug Administration (FDA) granted San Diego-based Cytori Therapeutics an IDE (investigational device exemption) in January, allowing the company to begin a prospective safety and feasibility trial of its system for bedside extraction, processing, and reinfusion of autologous adipose-derived regenerative cells (ADRCs) for treating hamstring injuries. ADRCs are thought to improve damaged or ischemic tissues though their ability to enhance blood flow and moderate inflammation, and surgeons in the European Union, Asia, and Australia are using the Celution System to repair soft tissue defects and treat cardiovascular disease.

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FDA approves US trial of Celution System

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