These cells are made available at the time of surgery using the celution system, an investigational device.
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. The independent, investigator-initiated study is being sponsored by Tatsuro Kamakura, chief medical officer of Cosmetic Surgery Seishin in Japan.
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 celution system. The primary endpoints will be cosmetic improvement volume retention at nine months.
Marc Hedrick, president for Cytori, said: “This study further demonstrates the breadth of potential applications for the celution system. A number of physicians like Dr Kamakura are interested in exploring new applications for the celution system through investigator-initiated studies. These studies will help accelerate and broaden the number of potential uses of the device and allow us in parallel to maintain our focus on the medical need of breast reconstruction in partial mastectomy patients.”