In the area of reconstructive surgery, Cytori is sponsoring a European clinical study for patients requiring breast reconstruction after lumpectomy for breast cancer.
Breast conserving therapy (BCT) or partial mastectomy for breast cancer is a treatment modality that involves surgery that is often followed by radiation therapy with the goal of preserving 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. Breast implants do not generallyaddress these defects and other surgical options are traumatic and require prolonged hospitalization. In patients with severe deformities, a tissue flap may be taken from the back and used to reconstruct the defect, but this approach requires at least one additional surgery, creates another defect and scar at the donor site and can be a long and expensive procedure. 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.
More than one million women worldwide are diagnosed with breast cancer annually. According to the American Cancer Society, the U.S. reports the greatest number of cases with an estimated 190,000 new diagnoses per year.
>>Learn More at ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT00616135
Study Status: Enrollment Complete/Patient Follow-up Ongoing
Cytori’s RESTORE 2 trial is a 70 patient European study designed to evaluate the transplantation of ADRC-enriched autologous (patient’s own) fat tissue into and around breast deformities. The study was designed to evaluate patients with a history of breast cancerwho have had surgical or endoscopic segmental mastectomy or quadrantectomy (lumpectomy) and are recurrence free. Data from this post-marketing study will also be used to support market adoption and insurance reimbursement for the procedure.
Enrollment was completed in November 2009. Patients are followed and evaluated for one year. Interim data from the 32 patients who had reached the six month follow up at the time of analysis was presented at the San Antonio Breast Cancer Symposium in December 2009. Final data will be available in the first half of 2011. This data will provide information on safety, volume retention, and patient and physician satisfaction.
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.