Enrollment Completed in Randomized Clinical Trial of Habeo™ Cell Therapy for Scleroderma and Impaired Hand Function
CYTORI THERAPEUTICS (CYTX)
Last cytori therapeutics earnings: 11/14 04:15 pm
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Source: GlobeNewswire
SAN DIEGO, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) announces completion of patient enrollment in SCLERADEC II (NCT02558543), a randomized, double-blind, placebo-controlled, parallel group, multi-center clinical trial intended to study the safety and efficacy of Habeo™ Cell Therapy in up to 40 subjects with impaired hand function due to scleroderma (systemic sclerosis). In this investigator-initiated clinical trial supported by Cytori, a total of 40 patients were enrolled among 5 French centers: Marseille, Montpelier, Rouen, Lyon, and Paris. The primary endpoint is improvement over baseline in the Cochin Hand Function Scale at 3 months. Full analysis of the unblinded data set, including results for secondary endpoints such as pain, quality of life, mobility, strength, tactile sensitivity, Raynaud’s Phenomenon, and vascular suppression, will be performed upon completion of the final patient’s 6 month follow-up visit. Data will be available in the
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