Scleroderma News

Cytori Therapeutics Inc. announced its FDA-approved phase 3 STAR trial has completed enrollment.

LONDON — At the EULAR Annual Congress, Dinesh Khanna, MD, MSc, spoke about the results of an open-label period of the faSScinate trial. The safety and efficacy of tocilizumab was assessed in patients with systemic sclerosis for 48 weeks of an open-label period.

Cytori Therapeutics Inc. announced the enrollment of the 80th patient in its FDA-approved phase 3 STAR trial.

The range of outcomes varies greatly for children impacted by juvenile or pediatric scleroderma. In the best case scenario, patients with localized disease may experience mild fibrosis of the skin, often on the extremities, that can resolve by adulthood. Children with systemic scleroderma usually face more severe complications, such as the disease impacting vital organs, including the heart and lungs.

DESTIN, Fla. — At the Congress of Clinical Rheumatology Annual Meeting, Fredrick M. Wigley, MD, spoke about treatment advances for patients with scleroderma. He said the disease expression is heterogeneous and it is important rheumatologists clearly define the clinical phenotype.

Cytori Therapeutics Inc. has announced its phase 3 STAR trial of a fat replacement treatment in the hands of patients with scleroderma has reached 75% of its target enrollment, according to a press release.

Fibrocell Science announced in a press release that it has received orphan drug designation from the FDA for its FCX-013 gene-therapy candidate to treat localized scleroderma.

About 85% of patients with systemic sclerosis who enrolled in a standardized, comprehensive, 2-day care pathway including visits with a rheumatologist, cardiologist, pulmonologist, occupational therapist, nurse and social worker, had a treatment intervention identified, according to recently published data.

The absence of tendon friction rubs and the presence of advanced fibrosis in patients with systemic sclerosis were predictive of treatment regression among 11 candidate predictors for skin improvement, according to recently published research.

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.