Investigator-Sponsored Cell Therapy Clinical Study for Scleroderma Initiated in France
<0> Cytori TherapeuticsTom Baker, +1-858-875-5258orMegan McCormick, +1-858-875-5279 </0>
(NASDAQ: CYTX) today announcedthat an investigator-sponsored and funded clinical study evaluating Cytori’s cell therapy as a potential treatment for and 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.
Scleroderma is a rare autoimmune disorder that results in an overproduction of collagen in the skin and vital organs. It ranges from mild to severe, is typically detected between the ages of 40 and 50, and it affects women four times more frequently than men. It is classified as localized or systemic. Two forms of systemic sclerosis include limited cutaneous and diffuse cutaneous, depending on the extent of skin fibrosis. In both subgroups, skin fibrosis affects the hands and leads to disability. Combined prevalence for limited and diffuse cutaneous systemic scleroderma in the G6 European countries is approximately 42,000 people. It is classified as an orphan disease by , a European consortium on rare diseases.
The study is being organized by a multidisciplinary team of researchers at Hộpital de le Conception. The researchers include Julie Veran, Cell Manufacturing Manager, Laurent Giraudo, Laboratory Chief Assistant, and Laurent Arnaud, Cell Characterization responsible, of the Cell Therapy Department. In addition, Aurelie Daumas, Chief Clinician Assistant from the Department of Internal Medicine, and Pierre Nguyen, M.D., Chief Clinician Assistant from the Department of Plastic & Reconstructive Surgery, will support implementation of the study. Per the request of the ANSM, the Department of Cell Therapy had previously validated the cell characterization, viability and reproducibility of the ADRCs processed by the Celution® System.
Cytori Therapeutics, Inc. is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple "ischemic" conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori's proprietary technologies and products, including the Celution® System product family.