Cytori Therapeutics Gets Conditional Approval For 'STAR' Trial In Scleroderma

(RTTNews) - Cytori Therapeutics, Inc. (CYTX) said the U.S. Food and Drug Administration or FDA has granted conditional approval for an Investigational Device Exemption or IDE for a pivotal study, named the 'STAR' trial, to assess Cytori Cell Therapy as a potential treatment for impaired hand function in scleroderma, a rare autoimmune disease affecting nearly 50,000 patients in the U.S.

The STAR trial is conditionally approved to be a randomized, double blind, placebo-controlled pivotal clinical trial of 80 patients in up to 12 U.S. sites. The trial evaluates the safety and efficacy of a single administration of Cytori Cell Therapy in scleroderma patients affecting the hands and fingers. The STAR trial intends to use the Cochin hand score, a validated measure of hand function, as the primary endpoint measured at 6 months after a single administration of Cytori Cell Therapy or placebo.

Scleroderma is a chronic autoimmune disorder associated with fibrosis of the skin, destructive changes in blood vessels and multiple organ systems as the result of a generalized overproduction of collagen.