cytori

·    |    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.

 

·         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.

 

“Following cancer treatment, the patient’s breast tissue can suffer from radiation injury, scarring and tight skin. This new technique is exciting because it may offer the opportunity to resolve some of the most difficult to treat conditions where other approaches, including fat alone, do not achieve satisfactory results.”Consultant Plastic and Reconstructive Surgeon Mrs. Eva Weiler-Mithoff, co-principal investigator at the NHS Glasgow Royal Infirmary Hospital.

 

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.

 

ADRC-enriched partial mastectomy breast reconstruction 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.