Cytori Reports Enrollment Completion In U.S. Phase III Scleroderma Trial

(RTTNews) - Cytori Therapeutics Inc. (CYTX) announced completion of enrollment for its U.S. FDA approved Phase III STAR trial. A total of 88 patients were enrolled ahead of schedule, and all procedures were completed successfully without complications.

STAR is a randomized, placebo-controlled, double-blind, parallel group phase III FDA approved pivotal study investigating the efficacy and safety of Cytori Cell Therapy (ECCS-50) injected subcutaneously into the fingers of patients with impaired hand function from scleroderma.

Approximately equal number of patients have received Cytori Cell Therapy and placebo. The double-blind period extends to 48 weeks. After all patients have completed 48 weeks follow-up, the placebo patients will be offered active treatment should they desire treatment and continue to qualify. Based on enrollment, data should be available mid-2017.