June 16, 2016
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Cytori Therapeutics completes enrollment for phase 3 scleroderma trial
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Cytori Therapeutics Inc. announced its FDA-approved phase 3 STAR trial has completed enrollment.
According to a company press release, STAR is a pivotal study to evaluate the efficacy and safety of injecting Cytori Cell Therapy (ECCS-50) subcutaneously into the fingers of patients with impaired hand function from scleroderma. A total of 88 patients have been enrolled and randomly assigned 1:1 to receive either Cytori Cell Therapy or placebo during the course of 48 weeks. Procedural complications were not observed.
After the study has been completed, patients in the placebo control group will be able to seek active treatment if they choose. Data are expected to be available in mid-2017, according to the release.
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