"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 P?©rez Cano, co-principal investigator for RESTORE 2 and Chief of Plastic Surgery Services at Hospital Universitario Gregorio Mara?±??n, 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.
Source Cytori