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Cytori provides update on scleroderma stem cell treatment study
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Cytori Therapeutics Inc. announced its phase 3 trial has met 50% of its targeted enrollment of patients with scleroderma treated with the stem cell therapy ECCS-50. The company also reported an independent data monitoring committee has recommended the study continue as planned following the review of data from the first 20 patients.
“We remain encouraged by how well the trial procedures have been tolerated and how the procedures have been instituted across the 20 study sites around the country,” Steven Kesten, chief medical officer of Cytori Therapeutics, said in a company press release. “We are grateful to the investigators, research staff and especially the patients who have participated and enabled us to remain on track to complete enrollment in mid-2016.”
The trial, dubbed the STAR trial, comes after a 12-patient SCLERADEC-I pilot trial with 2-year results presented at the Systemic Sclerosis World Congress in Lisbon, Portugal. One administration of ECCS-50 therapy appeared to be safe, and treated patients demonstrated improvements in hand symptoms, function and Raynaud’s syndrome through the 2 years following treatment. Once enrollment is complete for the STAR trial, 40 patients will be randomly assigned to ECCS-50 treatment and 40 will be assigned to placebo.
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