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.
At three months, breast circumference in the first three patients remained stable at an average increase of four 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. Further results from the study will be available following a nine month assessment of the primary endpoints of cosmetic improvement and volume retention.