February 2014

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. Cytori, which is also sponsoring a US trial of the technology for ischemic heart disease, hopes to open US markets for the system, which generates revenue through the sale of both the central device and its single-use per-procedure cartridges.

Trial investigators will initially enroll 10 patients with Grade 2 hamstring tears into two groups receiving different doses of ADRC therapy. Following a 90-day assessment of the first 10 patients, Cytori is approved by the FDA to expand the study with an additional 60 patients in a multicenter, double blinded, placebo-controlled trial looking at muscle healing, strength, function, and pain.

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