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.
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information, visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including without limitation, statements regarding safety and potential benefits of Cytori Cell Therapy (including statements suggesting that Cytori Cell Therapy may provide long term benefits across multiple scleroderma symptoms), and the possibility that other connective tissue disorders may be potentially attractive future targets for Cytori Cell Therapy, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, inherent risk and uncertainty in the conduct of clinical trials and clinical trial results (including risks associated with investigator-initiated trials), risks in the collection of clinical data (including collection and accuracy of the limited, open-label 12-patient SCLERADEC I pilot trial data), final clinical outcomes risks, risk regarding protection of intellectual property rights, regulatory uncertainties, risks regarding dependence on third party performance, competitive risks (including potential introduction of superior alternative therapeutic approaches to scleroderma), and performance and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading “Risk Factors” in Cytori’s Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.