Encouraging interim results from stem and regenerative cell-enriched fat grafting breast reconstruction trial

Interim results from a breast reconstruction trial show stem and regenerative cell-enriched fat grafting resulted in a high sustained rate of physician and patient satisfaction and persistent improvements in overall outcomes of the procedure at six and 12 months.

“These interim results are encouraging as we see consistent improvements in breast deformity, breast symmetry and tissue elasticity.”

Improvements in outcomes previously reported in 30 patients at six months were confirmed in a larger sample of 51 patients at six months. These improvements were sustained for the first 30 patients to reach the 12-month evaluation period.

The European trial, referred to as RESTORE 2, is sponsored by Cytori Therapeutics (NASDAQ: CYTX) and enrolled a total of 71 patients. The fat grafts in the study were enriched with stem and regenerative cells using Cytori's European-approved Celution® 800 System. The interim data reported today was presented at the Fifth Winchester-Jersey Masterclass in Oncoplastic Breast Surgery at the Royal Hampshire County Hospital.

Interim results from the RESTORE 2 trial demonstrated a high rate of physician and patient satisfaction at six and 12 months:

• Overall physician satisfaction with treatment results was 84% at six months in 51 patients
• Overall physician satisfaction with treatment results (90%) persisted in the first 30 patients at 12 months
• Overall patient satisfaction with treatment results was 73% in 51 patients measured at six months
• Overall patient satisfaction with treatment results (70%) persisted in the 30 patients at 12 months

"Medical research has found that untreated partial mastectomy defects negatively affects patients' psychology and quality of life," said Dr. Eva Weiler-Mithoff, M.D., co-principal investigator for RESTORE 2 at the Glasgow Royal Infirmary. "With reconstruction, patients are less likely to feel depressed or stigmatized and more likely to appreciate the treatment of breast cancer."

"A woman is not cured until she is reconstructed. Unfortunately for most patients, few options are available and there is currently no accepted standard-of-care for breast reconstruction," added Dr. Rosa Pérez Cano, co-principal investigator for RESTORE 2 and Chief of Plastic Surgery Services at Hospital Universitario Gregorio Marañón, Madrid, Spain. "These interim results are encouraging as we see consistent improvements in breast deformity, breast symmetry and tissue elasticity."

Cell-enriched breast reconstruction is a new procedure that addresses the unmet need created by partial mastectomy. This approach uses a woman's own fat tissue combined with her own naturally available adipose-derived stem and regenerative cells to form a 'cell-enriched' fat graft, which is used to reconstruct the affected breast.

In RESTORE 2, the cell-enriched graft was prepared by first extracting each patient's own stem and regenerative cells from their fat tissue using Cytori's Celution® 800/CRS System and then combining these cells with the fat graft, all in the same surgical procedure. More information on cell-enriched breast reconstruction and other reconstructive surgery options for breast cancer is available at www.cellreconstruct.eu.

RESTORE 2 is a post-marketing study primarily intended to measure physician and patient satisfaction in reconstructing the breast utilizing the Celution 800/CRS System. The study endpoints have been designed, among other things, to address hospital and physician reimbursement and adoption of the Celution® 800/CRS System throughout Europe. The outcomes of the study will be assessed at 12 months, per study design.