(RxWiki News) Not all breast cancer patients can safely undergo breast reconstruction. Radiation therapy, for example, can create an unfavorable environment for traditional breast reconstruction. A new technique gives these women an alternative.
A recently published clinical trial shows high patient satisfaction with a new breast reconstruction method that uses regenerative cells to restore breasts that have been deformed by cancer surgery.
"Thoroughly research and discuss all breast reconstruction options."
The RESTORE-2 trial involved 71 women at multiple clinics to evaluate the effectiveness of Cytori Therapeutics' autologous adipose-derived regenerative cell (ADRC)-enriched fat grafting technology (essentially stem cells derived from a woman's own fat).
It's used with women who have undergone partial mastectomies that have damaged the shape of the breast.
The method works by removing fat from a woman's hips, thighs, stomach or other areas using liposuction. The company has a proprietary system that extracts the woman's own regenerative (stem) cells from some of this tissue.
These cells are then combined with the remaining fat tissue to form what's known as an ADRC-enriched fat graft that's injected into the breast to restore its natural shape, look, feel and fullness.
The Celution system used to extract the cells is not commercially available in the United States.
The trial found that both patients and investigators were satisfied with the results of this procedure, including improved breast contour. There were no serious side effects or breast cancer recurrences related to the procedure.
The Director of Breast Plastic Surgery at Johns Hopkins, Gedge Rosson, M.D., told dailyRx, "This could be potentially a groundbreaking study — due to the fact that some surgeons are concerned that stem-cell enriched fat grafting could potentially increase the risk of breast cancer recurrence."
Dr. Rosson explains, "We eagerly await more long-term follow-up on these patients. To date, there have not been any studies completed in the United States."
He adds, "In the meantime, I feel it is important to stress that any patient interested in stem-cell enriched fat grafting absolutely must have it performed in the context of an Ethics Board (IRB)-approved clinical trial performed by a plastic surgeon, who is board certified by the American Board of Plastic Surgeons (ABPS) and is a member of the American Society of Plastic Surgeons. This would help ensure that the study is done in an ethical manner," said Dr. Rosson, who is also associate professor of plastic and reconstructive surgery at the Johns Hopkins School of Medicine.
Trial results were published in the March, 2012 issue of European Journal of Surgical Oncology.