BREAST RECONSTRUCTION STUDY INITIATED IN JAPAN.Cytori Therapeutics, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CYTX) (Frankfurt:XMPA XMPA X-ray Electron Microprobe Analysis XMPA Extensible Media Protection Architecture ) has received approval to begin an investigator-initiated safety and feasibility study in Japan using adult adipose adipose /ad·i·pose/ (ad´i-pos) 1. fatty. 2. the fat present in the cells of adipose tissue. ad·i·pose adj. Of, relating to, or composed of animal fat; fatty. (fat) derived stem and regenerative cells for breast reconstruction Breast Reconstruction Definition Breast reconstruction is a series of surgical procedures performed to recreate a breast. Reconstructions are commonly done after one or both breasts are removed as a treatment for breast cancer. . 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 mastectomy (măstĕk`təmē), surgical removal of breast tissue, usually done as treatment for breast cancer. There are many types of mastectomy. In general, the farther the cancer has spread, the more tissue is taken. . 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 adipose tissue (ăd`əpōs'): see connective tissue. adipose tissue or fatty tissue Connective tissue consisting mainly of fat cells, specialized to synthesize and contain large globules of fat, within a is a rich source for stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young 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 reconstructive surgery n. Plastic surgery. reconstructive surgery, n surgery to rebuild a structure for functional or esthetic reasons. . 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 subcutaneous tissue n. A layer of loose, irregular connective tissue immediately beneath the skin; it contains fat cells except in the auricles, eyelids, penis, and scrotum. . "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 comprises the College of Letters and Science (the primary undergraduate college), seven professional schools, and five professional Health Science schools. Since 2001, UCLA has enrolled over 33,000 total students, and that number is steadily rising. (UCLA UCLA University of California at Los Angeles UCLA University Center for Learning Assistance (Illinois State University) UCLA University of Carrollton, TX and Lower Addison, TX ), 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 Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test 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. For more information, call 858/875-5258 or visit http://www.cytoritx.com. |
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