RESTORE-2 is a 71 patient multi-center, prospective clinical trial using autologous adipose-derived regenerative cell (ADRC)-enriched fat grafting for reconstruction of the breast after cancer surgery. The majority of patients underwent radiation prior to the procedure, creating an unfavorable ischemic environment for which breast reconstruction with ADRC-enriched fat grafting appears to be ideally suited.
Key findings of the trial were:
- High rates of investigator (85%) and patient (75%) satisfaction with the overall treatment results at 12 months;
- High rates of investigator (87%) and patient (67%) satisfaction with overall breast deformity (based on functional and cosmetic outcomes) at 12 months;
- Improved breast contour at both six and 12 months, demonstrated by blinded MRI assessment; and
- No local cancer recurrences or serious adverse events related to the ADRC-enriched fat grafting procedure.
ADRC-enriched partial mastectomy breast reconstruction is marketed in the EU as the RESTORE Procedure and represents an innovative treatment option with significant cost savings potential. The procedure can be performed on an outpatient basis. Satisfactory results can be achieved in a single procedure for the majority of patients. In contrast, competitive approaches are more costly with lengthy hospital stays, require repeat procedures and increase the overall burden on the healthcare system. Furthermore, because of these limitations, physicians are often reluctant to recommend reconstruction for patients with partial mastectomy defects and radiation-induced damage in the breast.
Each year, approximately 450,000 European women are diagnosed with breast cancer. Of the newly diagnosed breast cancer cases, 70-80% are eligible for breast conserving surgery, where only a portion of the breast is removed rather than the full breast. In the European G5, there are an estimated 1.25 million women who have undergone partial mastectomy. The majority of these patients are left with a sizeable volume defect, scarring and often radiation damage.
"Given that there is no widely accepted reconstructive option available today for partial mastectomy patients, this procedure could well address this substantial unmet need and help complete the overall cancer treatment," said Marc H. Hedrick, president of Cytori.
About the RESTORE Procedure
During the RESTORE Procedure, fat is taken from the patient's stomach, hips, thighs, or other areas by liposuction. Some of the tissue is processed in Cytori's Celution® system to extract the patient's own regenerative cells which occur naturally inside the tissue. The extracted cells are then combined with the remaining fat tissue, forming an ADRC-enriched fat graft that is injected into the breast to restore its natural look and feel. In addition to providing an entirely natural reconstruction, the procedure is minimally invasive with the potential to reduce scarring. The Celution® system is not commercially available in the United States.
About the RESTORE-2 Trial
RESTORE-2 is a 71 patient European post-marketing trial primarily intended to measure patient and physician satisfaction in reconstructing the breast utilizing the Celution® system. The trial took place at the following sites: Hospital General Universitario Gregorio Marañón in Madrid, Spain, Glasgow Royal Infirmary in Glasgow, Scotland, KU Leuven University Hospitals in Leuven, Belgium, Azienda Ospedaliero Universitaria Careggi in Florence, Italy, Instituto Valenciano Oncología in Valencia, Spain, Norfolk and Norwich University Hospital in Norwich, England, and Jules Bordet Institute of Cancer in Brussels, Belgium.