Encouraging interim results from stem and regenerative cell-enriched fat grafting breast reconstruction trial
March 17, 2016
"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.