Cytori Therapeutics recently announced that its FDA-approved Phase 3 STAR clinical trial evaluating ECCS-50 has enrolled and treated its 80th patient, reaching 100 percent of its target enrollment. Because of the strong interest and fast screening across the trial clinical sites, additional patients will be enrolled, so the final enrollment will…
News
Clopidogrel (Plavix) treatment may worsen blood vessel dysfunction and lead to the development of new digital ulcers in patients with scleroderma. The results of this proof-of-concept study indicated that platelet activation is not a main driver of fibrosis, also highlighting the need for caution when treating scleroderma patients who also…
Immune T-cells induced by the autoantigen topoisomerase-I were linked to lung fibrosis and found to predict disease progression in scleroderma patients. The finding may open new avenues of research into treatments that selectively target the various tissue-specific disease manifestations of scleroderma — a substantial improvement to the nonselective immunosuppression used today.
Cell therapy company Cytori Therapeutics recently announced the presentation of an update on the clinical trials SCLERADEC I and II, which are investigating the use of Cytori Cell Therapy in the treatment of scleroderma-related hand dysfunction, at the 104th Annual Meeting of the Japan Society of Aesthetic Surgery in Tokyo, Japan. The…
Edward Harris, the man behind the Scleroderma Education Project, recently presented a review and analysis of published data about therapeutic plasma exchange (TPE), a potential technique for treating scleroderma, at the American Society for Apheresis (ASFA) 2016 Annual Meeting. The presentation, “Therapeutic Plasma Exchange for the Treatment…
A Phase 2 clinical trial investigating the efficacy and safety of tocilizumab, an interleukin 6 receptor-α inhibitor, revealed a clinically significant — although not statistically significant — improvement of skin sclerosis and lung function in patients with systemic sclerosis. The findings were published in The Lancet journal, in…
In the lung’s extracellular matrix (ECM) — observed in both cultured cells from systemic sclerosis patients and a mouse model — the protein netrin-1 was seen to regulate the accumulation of collagen-producing fibrocytes and promote pulmonary fibrosis. The study, “Netrin-1 Regulates Fibrocyte Accumulation in the Decellularized Fibrotic Sclerodermatous Lung Microenvironment and in Bleomycin-Induced Pulmonary Fibrosis,” published…
Cumberland Pharmaceuticals, Inc., recently announced the addition to its drug pipeline of Vasculan (ifetroban), an oral capsule that soon will enter clinical testing as a treatment of systemic sclerosis (SSc), or scleroderma. Vasculan is being evaluated for safety and efficacy in a randomized, double-blind and placebo-controlled Phase 2 clinical study in people with…
The Phase 3 STAR clinical trial from Cytori Therapeutics recently enrolled and treated its 60th patient — 75 percent of target patient enrollment. The FDA-approved Phase 3 STAR study is assessing the one-year safety and efficacy of the Celution Therapy ECCS-50 in the processing of an autologous graft consisting of adipose (fat) derived…
FDA Grants Orphan Drug Designation to Fibrocell’s FCX-013, a Gene Therapy for Localized Scleroderma
The U.S. Food and Drug Administration (FDA) has designated a potential gene therapy for localized scleroderma, FCX-013 by Fibrocell Science, an orphan drug to help advance its development and testing. Fibroblasts, the basis of Fibrocell’s personalized cell and gene therapy platform, are the most common cell in skin and connective tissue, and responsible…
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