Cytori Therapeutics (NASDAQ: CYTX) today announced that an investigator-sponsored and funded clinical study evaluating Cytori’s cell therapy as a potential treatment for limited and diffuse cutaneous systemic sclerosis (scleroderma) has been approved to begin in France by the National Agency for the Safety of Medicines and Health Products (ANSM, formerly AFSSAPS). The study will be conducted by Professor Guy Magalon, M.D., Chief of the Division of Plastic Surgery and Professor of Universities, at Hộpital de la Conception, AP-HM Marseille, France, Professor Brigitte Granel, M.D., Department of Internal Medicine of Hospital Nord and Professor of Universities, and Professor Florence Sabatier, M.D., Head of the Department of Cell Therapy.
“We are interested in investigating Cytori’s cell therapy as a potential treatment for scleroderma because earlier data suggest it can improve blood flow and minimize the immune response,” said Professor Magalon. “Based on these properties, the treatment has the potential to reverse the ischemic effects, where there is tightening of the arteries in the affected areas, and counter the autoimmune reaction. While this research is in its early stages, if we begin to observe encouraging efficacy, we intend to expand the trial to include more hospitals and patients.”
Per the study protocol, 13 patients will receive an injection of their own adipose-derived stem and regenerative cells (ADRCs) into the affected areas of their fingers. ADRCs will be processed using Cytori’s automated Celution® System so that their own cells may be redelivered immediately. The primary endpoints are safety and the improvement in function of the hands, as measured by the Cochin hand functional scale at six months. Secondary endpoints include severity of pain visual analog scale, Systemic Sclerosis Health Assessment Questionnaire, Rodnan score adapted to the hand, HAMIS test, and severity of the Raynaud’s syndrome. The first patient in the study is expected to be treated in November 2012.