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Cytori Therapeutics reaches target enrollment for phase 3 scleroderma trial
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Cytori Therapeutics Inc. announced the enrollment of the 80th patient in its FDA-approved phase 3 STAR trial.
The STAR trial is a pivotal study to investigate the efficacy and safety of Cytori Cell Therapy injected subcutaneously into the fingers of patients with impaired hand function from scleroderma, according to a company press release. Currently, all 80 patients receiving either Cytori Cell Therapy or placebo have been successfully treated without complications. The release noted final patient enrollment will exceed the original target of 80 patients. With reportedly increased interest and rapid screening across multiple trial sites, additional patients are being enrolled into the trial and full trial data are expected to be available in mid-2017.
“The collaboration of our industry, health care professions, health care institutions and patients has led to our ability to fully enroll the STAR trial ahead of schedule,” Steven Kesten, MD, chief medical officer of Cytori Therapeutics, said in the release. “We are now one step closer to having Cytori Cell Therapy available to patients suffering from hand problems due to scleroderma. It is critical that we remain focused on careful and accurate data collection through the follow-up period. Even though the patients, the investigators and Cytori remain blinded, we can say that the procedures are feasible and were well-tolerated by the STAR patients.”
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