SAN DIEGO -- (BUSINESS WIRE) -- Cytori Therapeutics (NASDAQ: CYTX) today announced that six month outcomes from a 12 patient independent investigator-initiated study using Cytori Cell Therapy to treat scleroderma have been published in the Annals of Rheumatic Disease. The article is currently available online.
Data from the study indicated that treatment with Cytori Cell Therapy was safe and well tolerated through six months. In addition, the data indicated an approximately 50% average improvement across four key, validated endpoints used to assess the clinical status in patients with systemic scleroderma with impaired hand function at two months, with benefits sustained through six month follow-up.
“After six month follow up, we are encouraged by the results that have been seen by the investigators in France,” said Dr. Steven Kesten, Chief Medical Officer, Cytori. “The reductions in hand pain, Raynaud’s Phenomenon and improvements in hand function are consistent with a therapy that promotes angiogenesis and modulates the inflammatory response. The outcomes suggest that Cytori Cell Therapy could help address these persistent symptoms for which therapeutic options are limited in efficacy and/or are accompanied by significant cost and side effects. The investigators in Marseille have continued to follow the patients and are considering a larger, controlled study based on these positive outcomes.”
As part of the study, 12 female patients received subcutaneous dosing of Cytori Cell Therapy into each finger. Cytori Cell Therapy is a mixed population of adipose-derived regenerative cells (ADRCs™) extracted from the patient’s own adipose tissue using Cytori’s proprietary Celution® System at the point-of-care. Safety was the primary outcome of the study at two and six months; the procedure was well tolerated in all patients, with no serious adverse events. Sustained, statistically significant improvements in key secondary endpoints, including hand disability and pain, Raynaud’s phenomenon (discoloration of extremities and pain due to dramatically reduced blood flow) and quality of life, were observed at both two and six months:
Scleroderma is a chronic autoimmune disorder that causes skin fibrosis and destructive changes in blood vessels as the result of collagen overproduction in the skin and vital organs. While the disease often affects multiple organs, it most commonly causes chronic changes in the skin and the hands, causing profound disability, diminished mobility and pain. There are no approved therapies that effectively treat all manifestations of scleroderma in the hands. Current treatment programs are focused on Raynaud’s phenomenon and are primarily aimed at symptom relief rather than treating the underlying condition. These treatments can be costly and may result in substantial adverse events. Cytori Cell Therapy has the potential to improve healing following tissue injury by reducing inflammation, restoring blood flow and stimulating local repair cells. In the United States, approximately 75,000 patients suffer from scleroderma, with the vast majority of these patients suffering from hand manifestations of the disease.
The study was conducted by Professor Guy Magalon, M.D., Chief of the Division of Plastic Surgery and Professor of Universities, at Hôpital 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 as well as a multidisciplinary team of researchers at Hôpital de le Conception.
About Cytori Therapeutics
Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs™). Our scientific data suggest ADRCs™ improve blood flow, modulate the inflammatory response and rescue tissue at risk of dying. As a result, we believe these cells can be used to treat cardiovascular disease and other medical conditions. These cell therapies are made available to the physician and patient at the point-of-care through the use of Cytori’s proprietary Celution® System. www.cytori.com
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding future events and expectations, including but not limited to the potential for Cytori Cell Therapy to address persistent symptoms of scleroderma in the hands, plans to continue following patients and potential plans for additional studies. These forward-looking statements involve risks and uncertainties, including regulatory uncertainties, the performance of our products in this indication, dependence on third-party performance, as well as other factors which may be beyond the Company’s control. For additional disclosure regarding these and other risks faced by Cytori Therapeutics, we refer the reader to carefully review the section titled "Risk Factors" in Cytori's filings with the SEC, including its annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. Cytori assumes no responsibility to update any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.