Cytori Announces Two Year Follow-Up Published On EU Scleroderma Trial

(RTTNews) - Cytori Therapeutics, Inc. (CYTX) announced Tuesday the publication of two-year clinical follow-up of patients treated with a single administration of ECCS-50 in the SCLERADEC-I pilot trial of Cytori Cell Therapy in patients with hand dysfunction associated with scleroderma.

The late stage cell therapy company developing autologous cell therapies from adipose tissue noted that the authors report that key clinical benefits reported at the 6-month time point of the trial were sustained at two years.

The SCLERADEC I trial was a 12 patient, single arm, open label study. The primary endpoint, Cochin Hand Function Score improved 62.5% over baseline. Key secondary endpoints also improved from baseline. Specifically, pain was reduced, scleroderma-associated disability was reduced by 51.1%, and Raynaud's Condition Score improved by 88.3%.

In addition, key objective measures of scleroderma hand involvement showed sustained benefit: digital ulcers remained reduced from baseline by 60% and improvement in pinch strength was also sustained.

The company said trends indicating improvement in hand mobility were also reported. Also, eight patients who had been treated previously with prostanoids had not required subsequent re-treatment with these agents in the two year follow up period.

Marc Hedrick, Cytori's President & Chief Executive Officer, said, "The long-term follow data from this small, open label trial, continues to suggest that a single administration is safe and may provide long term benefits across multiple scleroderma symptoms. Scleroderma is a very complex disease but shares common features with other connective tissue disorders that may be attractive future targets for the therapy."

The results were published in the journal Current Research in Translational Medicine.