Cytori Therapeutics: FDA Approves Scleroderma Trial - Quick Facts

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

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.