Cytori shares progress report on phase 3 scleroderma fat injection trial

Cytori Therapeutics Inc. announced it has enrolled 20 patients into its STAR scleroderma trial, meeting 25% of its target enrollment in the study of fat harvest from small volume liposuction and finger injection, according to a company press release.

“We are very encouraged by the study progress and the commitment of our study centers to the STAR trial. In addition, we have been able to demonstrate that same-day fat harvest, cell processing and finger injection is feasible and has been performed safely in multiple U.S. centers, as was demonstrated in the single center SCLERADEC-I trial performed in France,” Steven Kesten, MD, chief medical officer of Cytori Therapeutics, said in the release.

The STAR trial is a randomized, placebo-controlled, double-blind, parallel group, phase 3 study designed to investigate the efficacy and safety of Cytori Cell Therapy (ECCS-50) injected subcutaneously into the fingers of patients with hand dysfunction from scleroderma complications. When the target of 80 patients is met, 40 patients will be randomized to treatment with Cytori Cell Therapy and 40 patients will receive placebo. After 48 weeks, patients who received placebo will be invited into active treatment following a successful trial. Enrollment is expected to be completed by mid-year.

Cytori plans to present further study details at the World Systemic Sclerosis World Congress, which is scheduled for Feb. 18 to 20, 2016 in Lisbon, Portugal.

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