Reconstructive Surgery

In the area of reconstructive surgery, Cytori is sponsoring a European clinical study for patients requiring breast reconstruction after lumpectomy for breast cancer.

There are limited reconstructive options to address tissue defects and asymmetry which commonly result from segmental mastectomy or quadrantectomy (lumpectomy). Breast implants do not adequately address these defects and other surgical options are traumatic and require prolonged hospitalization. Transplantation of autologous (patient’s own) fat tissue has been tried, with unpredictable results due to variable rates of fat transplant retention over time. With the RESTORE-2 study, Cytori hopes to discover that enriching a patient’s fat graft with her own Adipose-Derived Stem and Regenerative Cells (ADRCs) will improve graft survival as well as patient and physician satisaction.

RESTORE-2 
>>Learn More at ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT00616135
Study Status: Enrollment Open/Actively recruiting potential patients

Cytori’s RESTORE-2 trial is a European study designed to evaluate the transplantation of ADRC-enriched autologous (patient’s own) fat tissue into and around breast deformities. Data from this post-marketing study will also be used to support market adoption and insurance reimbursement for the procedure.

Enrollment is currently open and study investigators are actively looking for potential patients with a history of breast carcinoma who have had surgical or endoscopic segmental mastectomy or quadrantectomy (lumpectomy) and are recurrence free. It is expected that the sites will enroll up to 70 patients. Patients are followed and evaluated for one year. Data will be analyzed in 2010. This data will provide information on safety, volume retention, and patient and physician satisfaction.

restore-2 

The following sites are participating in the study: Hospital Universitario Gregorio Marañón in Madrid, Spain, Glasgow Royal Infirmary in Glasgow, Scotland, Università degli Studi di Firenze in Florence, Italy, IVO Fundación in Valencia, Spain, Jules Bordet Institute of Cancer in Brussels, Belgium, Princess Alexandra Hospital in Essex, UK, Norfolk and Norwich University Hospital in Norwich, UK, and KU Leuven University Hospitals in Leuven, Belgium.