Cytori Reports Promising Results in Cell-Enriched Breast Reconstruction Trial
Interim results from a European clinical trial, RESTORE 2, demonstrate that cell-enriched breast reconstruction achieved a high rate of patient and physician satisfaction and improvements in overall breast deformity in lumpectomy patients. These results are based on six-month follow up from the first 32 women enrolled and treated. The results were presented at the 32nd Annual CTRC-AACR San Antonio breast cancer Symposium by Dr. Eva Weiler-Mithoff, M.D., co-principal investigator for the Restore 2 Trial at the Glasgow Royal Infirmary.
The highlights from the interim data of Cytori Therapeutics’ (NASDAQ: CYTX) RESTORE 2 clinical trial include:
- A high rate of patient satisfaction (73%) and physician satisfaction (82%) with the overall outcome after a single treatment was reported in difficult to treat breast cancer patients
- Mean patient and physician satisfaction scores dramatically improved for breast symmetry, scarring and deformity from baseline to six month follow-up
- Qualitative analyses of imaging data confirmed clinical improvement in both breast defect and overall breast shape
Breast conserving therapy (BCT) or partial mastectomy for breast cancer is a surgical technique that preserves as much native tissue as possible, focusing tissue removal on the target area affected by cancer plus some surrounding tissue for margin. The majority of patients treated with breast cancer today receive BCT. Although the goal is to protect as much of the patient’s own tissue as possible, the procedure can create a deformity that can be extremely difficult to repair. In patients with severe deformities, a tissue flap may be taken from the back and used to reconstruct the defect, but requires at least one additional surgery, creates another defect and scar at the donor site and can be a long and expensive procedure. For most patients however, there are no good reconstructive options.
Cell-enriched breast reconstruction is a new procedure which addresses this unmet need created by BCT. In this approach, a woman’s own fat tissue is combined with her own naturally available adipose-derived regenerative cells (ADRCs). The ‘cell-enriched’ fat graft is then injected into and around the defect area. In RESTORE 2, the ADRCs were extracted from the patient’s own fat tissue using Cytori’s Celution® 800/CRS System.
RESTORE 2 is a post-marketing study primarily intended to measure patient and physician satisfaction in reconstructing the breast utilizing the Celution® 800/CRS System. The goal is to support 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. The co-principal investigators for RESTORE 2 are Dr. Weiler-Mithoff, Consultant Plastic and Reconstructive Surgeon and Dr. Rosa Pérez Cano, Chief of Plastic Surgery Services at Hospital Universitario Gregorio Marañón in Madrid, Spain.
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