Cytori Therapeutics (CYTX) Announces Publication of Follow-up ECCS-50 Data in Scleroderma
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Cytori Therapeutics, Inc. (Nasdaq: CYTX) announced 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 results, published by Dr. Brigitte Granel and colleagues of the Assistance Publique des Hôpitaux de Marseille, were published in the journal Current Research in Translational Medicine. The manuscript is now accessible online.
The authors report that key clinical benefits reported at the 6-month time point of the trial were sustained at two years (follow up range of 22–30 months). The primary endpoint, Cochin Hand Function Score improved 62.5% over baseline (18.6±13.8 at two years vs. 48.5±10.8; p<0.0001). Key secondary endpoints also improved from baseline. Specifically, pain was reduced from 59.4±17.2 at baseline to 29.5±25.2 at two years (p=0.02), scleroderma-associated disability was reduced by 51.1% (0.7±0.5 vs. 1.4±0.3; p=0.0051), and Raynaud’s Condition Score improved by 88.3% (0.8±0.9 vs. 7.2±0.9; p<0.0001).
In addition, key objective measures of scleroderma hand involvement showed sustained benefit: digital ulcers remained reduced from baseline by 60% (6 vs. 15 at baseline) and improvement in pinch strength was also sustained. Trends indicating improvement in hand mobility were also reported. An interesting finding noted by the authors was that 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.
“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,” said Dr. Marc H. Hedrick, M.D., Cytori’s President & Chief Executive Officer. “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 SCLERADEC I trial was a 12 patient, single arm, open label study led by Drs. Brigitte Granel and Guy Magalon of APHM supported by the team of Pr. Florence Sabatier of the Cell Therapy Department of Hôpital de le Conception, Assistance Publique-Hôpitaux de Marseille.
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