Cytori Therapeutics announced completion of enrollment in U.S. Phase III Scleroderma Trial
OREANDA-NEWS. Cytori Therapeutics, Inc. (NASDAQ: CYTX) today 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. Details of the STAR trial including inclusion and exclusion criteria can be found at the following link: clinicaltrials.gov
About Cytori
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.
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