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 Therapy™ acts principally by improving blood
flow, modulating the immune system, and facilitating wound repair. As a
result, Cytori Cell Therapy™ 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.
Copyright Business Wire 2015