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Cytori's Celution System Under Evaluation for Breast Augmentation as Part of Investigator Initiated Study

08 Nov 2007 - A new study underway in Japan will examine the effect of adult stem and regenerative cells derived from adipose tissue in breast augmentation. In this investigational procedure, a patient's breast is augmented with her own liposuctioned fat, which has been combined and enhanced with her own adipose-derived stem and regenerative cells. These cells are made available at the time of surgery using the Celution(TM) System - an investigational device developed by Cytori Therapeutics. This independent, investigator-initiated study is being sponsored by Tatsuro Kamakura, MD, Chief Medical Officer of Cosmetic Surgery Seishin in Japan.
 
Fat, known medically as adipose tissue, is one of the body's richest and most accessible sources of regenerative cells. Adipose-derived regenerative cells include adult stem cells in addition to other important cell types that have been shown pre-clinically to improve tissue retention compared to non 'cell enhanced' tissue transfers. For this reason, these cells potentially may improve and simplify traditionally complex fat transfer procedures as well as enable more predictable outcomes and graph retention when applied to cosmetic and reconstructive surgery.
 
The study will enroll 20 patients, all of whom will undergo a standardized cell enhanced fat tissue transplantation procedure, whereby the cells are processed with Cytori's Celution(TM) System. The primary endpoints will be cosmetic improvement volume retention at nine months. The study is being sponsored by Dr. Kamakura. Clinical research is ongoing for breast reconstruction in partial mastectomy patients. The Celution(TM) System was evaluated in an 11-patient investigator-initiated safety and feasibility study, designated as RESTORE I, conducted in Japan. This study evaluated adipose-derived stem and regenerative cells extracted and processed with the Celution(TM) System to treat the complications of surgery and radiation damage following partial mastectomy.