Cytori Therapeutics announced today that the Center for Biologics Evaluation and Research (CBER), a division of the U.S. Food and Drug Administration (FDA), has given final approval to its application for an Investigational Device Exemption (IDE) to begin a pivotal trial to evaluate Cytori Cell Therapy™ as a potential treatment for impaired hand function in scleroderma.

“We are pleased to be one step closer to bringing cell therapy into the mainstream of medicine,” said Marc H. Hedrick, M.D. President and CEO of Cytori Therapeutics. “The pilot trial data showed evidence that our lead therapeutic could substantially improve hand function and overall quality of life in this group of patients that today have limited effective therapeutic options.”

The STAR trial will begin enrolling in 2015 and will include 80 patients, in up to 12 centers in the United States. The trial is a randomized, double-blind, placebo-controlled study of the safety and efficacy of a single administration of Cytori’s lead cellular therapeutic, ECCS-50, in scleroderma patients with hand dysfunction. The impairment in hand function is typically progressive and can result in chronic pain, blood flow changes and often profound disability. The available treatments often have minimal impact and those for advanced disease are often accompanied by significant adverse effects.

“We are extremely excited about the approval of the STAR trial. Dr. Dinesh Khanna, one of the principal investigators, is a widely respected international scleroderma expert, and his participation is a strong endorsement of this trial. The International Scleroderma Network welcomes this novel therapeutic approach, which aims to improve scleroderma hand function. If this advanced cell therapy by Cytori Therapeutics proves effective, this will represent a unique and deeply needed option for patients,” said Shelley Ensz, Founder and President, International Scleroderma Network.