Cytori (NASDAQ:CYTX) received approval to begin its European stem and regenerative cell-enhanced breast reconstruction study in breast cancer patients who have undergone partial mastectomy. This is a post-market study designated as RESTORE II. Currently, there is no generally accepted reconstructive technique for partial mastectomy patients despite the fact that breast conserving therapy is standard practice in the treatment of women with breast cancer worldwide.

In this study, tissue loss resulting from partial mastectomy will be reconstructed with the patients’ own fat tissue (adipose), which will be enhanced with their adipose-derived stem and regenerative cells. This procedure is referred to as cell-enhanced reconstruction. The cells in RESTORE II will be made available at the time of surgery using Cytori's Celution^® 800 System.

The primary goal is to obtain European reimbursement for cell-enhanced reconstruction using the Celution^® 800 System by measuring key quality of life improvements in breast cancer patients desiring reconstruction. Up to 70 women will be enrolled at six clinical centers in the U.K., Italy, Spain, and France. Primary endpoints will be patient and physician satisfaction with functional and cosmetic outcomes at six and 12 months after surgery. Cytori’s goal is to complete enrollment before the end of March 2009.

“RESTORE II is important for advancing reconstructive options for women with breast cancer,” said Professor Emmanuel Delay, the study’s principal investigator and Chief of Plastic and Reconstructive Surgery at The Leon Bérard Cancer Center in Lyon France. “A successful study should broaden availability of this therapy to partial mastectomy patients in Europe.”

“Unfortunately fewer options are available to women desperate for reconstructive surgery following partial mastectomy due to the effects of the adjuvant radiotherapy,” said Mrs. Eva Weiler-Mithoff, surgeon at the Glasgow Royal Infirmary, and lead investigator for the U.K. study site. “Adipose tissue enriched with stem and regenerative cells represents a new approach that we believe allows for predictable graft retention.”

“My ongoing clinical experience using Cytori’s Celution^® 800 System in breast reconstruction has been very encouraging,” said Professor Claudio Calabrese, Associate Professor of Surgery and lead investigator at University of Florence Hospital.