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Cytori Therapeutics, Inc. (NASDAQ:CYTX) (Frankfurt:XMPA) has received approval to begin an investigator-initiated safety and feasibility study in Japan using adult adipose (fat) derived stem and regenerative cells for breast reconstruction. This study has been approved by the Institutional Review Board and the first patient has been enrolled and is scheduled to be treated in May.

The study is being initiated and conducted by Keizo Sugimachi, M.D., president, Kyushu Central Hospital in Fukuoka, Japan, in conjunction with Cytori using the company's Celution(TM) System to isolate and concentrate the patients' stem and regenerative cells. This is the first Celution(TM) System to be installed in Asia and utilized in a clinical study. More than one million women worldwide are diagnosed with breast cancer annually. Fortunately, early detection has served to increase the number of women eligible for partial mastectomy. This approach, though effective in the treatment of breast cancer, can often result in significant skin damage and tissue loss. There is an important unmet clinical need for treatments that restore the soft tissue and it is believed that stem cell therapies may play an important future role in this area. "Adipose tissue is a rich source for stem cells and other regenerative cells that are believed to contribute to repair and healing," said Dr. Sugimachi. "As a result, adipose-derived stem and regenerative cells could potentially offer breast cancer patients the option to use their own cells to restore a natural breast contour following surgery, obviating the need for an implant or complicated surgical procedure. Currently, there are few natural alternatives for breast reconstruction, creating a significant need for innovative procedures such as this one, now being investigated with adipose stem and regenerative cells."

Study Procedure & Protocol

The clinical study will be an open label, safety and feasibility study in breast cancer patients who have undergone a partial mastectomy. The study is expected to enroll up to 20 patients. In addition to safety, the study will evaluate volume retention as well as other outcomes of reconstructive surgery.

As part of the study, each patient will have a small volume of tissue removed from one or more of the body's normal fatty depots. The Celution(TM) System will extract and concentrate a stem and regenerative cell-enriched fraction that will be delivered to the affected areas of the breast and subcutaneous tissue.

"The primary aim of this study is to evaluate the safety of adipose-derived stem and regenerative cells, extracted and concentrated by our Celution(TM) System at the patient's bedside in a single surgical procedure," said Marc H. Hedrick, M.D., president, Cytori Therapeutics. "Based on our extensive pre-clinical data, we believe the effect of the Celution(TM) output is safe and may improve the appearance of the breast after cancer surgery."

Adipose Stem and Regenerative Cells and The Celution(TM) System Adipose tissue is an abundant source of stem and regenerative cells that can contribute to the repair and healing of damaged tissue. As a result, this source is uniquely suited for real-time cell therapy utilizing a patient's own cells. It was first reported that stem cells reside in adipose tissue by a team from The University of California, Los Angeles (UCLA), led by Marc H. Hedrick, M.D., now the president of Cytori Therapeutics.

The Celution(TM) System is designed to automate the proprietary process and methods developed by Cytori scientists to isolate and concentrate a high yield of a patient's own stem and regenerative cells from adipose tissue without the need for cell culture (repeated cell divisions). The Celution(TM) System can process whole adipose tissue into isolated and concentrated stem and regenerative cells from start to finish in approximately one hour.

About Cytori Therapeutics

Cytori Therapeutics, Inc. (NASDAQ:CYTX) (Frankfurt:XMPA) is discovering and developing proprietary cell-based therapeutics utilizing adult stem and regenerative cells derived from adipose tissue, also known as fat. The company's investigational therapies target cardiovascular disease, spine and orthopedic conditions, gastrointestinal disorders and new approaches for aesthetic and reconstructive surgery. To facilitate processing and delivery of adipose stem and regenerative cells, Cytori has developed its proprietary Celution(TM) System to isolate and concentrate a patient's own stem and regenerative cells in about an hour. This system will dramatically improve the speed in which personalized cell-based therapies can be delivered to patients.

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Publication:Worldwide Biotech
Date:Jun 1, 2006

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