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ARTICLE | Clinical News

Cytori's Habeo Cell Therapy misses in Phase III scleroderma trial

August 11, 2017 5:51 PM UTC

Cytori Therapeutics Inc. (NASDAQ:CYTX) reported top-line data from the Phase III STAR trial in 88 patients with hand dysfunction due to scleroderma showing that Habeo Cell Therapy (ECCS-50) missed the primary endpoint of improving mean Cochin Hand Function Score (CHFS) from baseline to weeks 24 and 48 vs. placebo as measured by both ANCOVA and mixed model repeated measure (MMRM) analyses. Habeo Cell Therapy also missed the secondary endpoints of improving mean Health Assessment Questionnaire-Disability Index (HAQ-DI) and Raynaud’s Condition Score vs. placebo.

Patients in the double-blind, U.S. trial received a single subcutaneous injection of 40 million cells of the Habeo Cell Therapy into the affected fingers. The product comprises autologous adipose-derived regenerative cells (ADRCs) separated and concentrated using Cytori’s Celution 800 System...

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