FDA Approves Expansion of Pivotal Scleroderma STAR Trial to 20 Clinical Sites
Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today that it received approval from FDA to expand the number of Scleroderma clinical trial sites from 12 to 20 centers in the United States. The STAR study is an 80 patient pivotal clinical trial approved by FDA in January 2015 to study the effects of Cytori’s lead drug ECCS-50 for treatment of patients with hand manifestations of Scleroderma.
“Increasing the number of trial sites to 20 institutions should make the STAR trial more accessible to physicians and patients with scleroderma,” said Dr. Steven Kesten, Chief Medical Officer of Cytori Therapeutics. “There are only about 35 specialized scleroderma centers in the U.S. and this decision to expand the trial sites by FDA allows us to substantially broaden the geographic coverage of the trial, increase the number of centers trained in the use of this therapeutic and ultimately facilitate trial enrollment.”
About Cytori Therapeutics, Inc.
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell TherapyTM acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell TherapyTM may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information: visit www.cytori.com.
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