Three Month Results Reported from Stem & Regenerative Cell Breast Augmentation Study
Friday, May 16, 2008 8:09 AM
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Early results were reported from an independent study in Japan using adipose-derived stem and regenerative cells for breast augmentation. Early results on the first three patients from this investigator-initiated study showed the increase in breast volume was maintained at three months and that the tissue remained soft and natural. The findings were reported earlier this week by the investigator, Tatsuro Kamakura, M.D., Chief Medical Officer of Cosmetic Surgery Seishin, at the 94th Bi-Annual Congress of the Japan Society of Aesthetic Surgery (www.biyou-clinic.jp/jsas/).

"Volume retention and softness of tissue at three-months is extremely encouraging compared to typical outcomes in non-cell-enhanced fat transfers,” said Dr. Kamakura. “If volume retention holds at nine-months, the augmentations can be expected to be permanent. Such results offer women a revolutionary new cosmetic surgery option for smaller volume augmentations, where a more natural look and feel is desired."

At three months, breast circumference in the first three patients remained stable at an average increase of 4 centimeters, which is equivalent to a 1.6 cup size increase. An average net volume of 160mL (less saline) of cell enhanced fat tissue was transplanted into each breast of each patient. The procedure to date has been found safe with no report of any adverse events. Patient follow-up is ongoing in this 20 patient investigator-initiated study. Nine-month results will be reported in early 2009, shortly after the last patient follow-up.

The study is using a procedure whereby a woman’s fat tissue is enriched with her own adipose derived stem and regenerative cells to create a natural filler. This technique is referred to as cell-enhanced augmentation. The cells in the study were made available at the time of surgery using the Celution® 800 System from Cytori Therapeutics (NASDAQ: CYTX). Further results from the study will be available following a nine month assessment of the primary endpoints of cosmetic improvement and volume retention.

Fat, known medically as adipose tissue, is the body's richest known source 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.


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