Cytori Therapeutics was informed that positive longer-term follow-up data were presented from an independent, investigator-sponsored breast reconstruction study in Japan.
As part of the study, adipose tissue-derived stem and regenerative cells, processed with Cytori's Celution 600 System, were used to reconstruct breast tissue following partial mastectomy. New data from the study showed:
- Patient satisfaction remained at 79 percent, with a mean follow-up of 12-months
- The procedure remains safe and well tolerated
- There was no significant loss of breast tissue thickness from one month to a mean follow up of 12-months
The procedure reconstructed partial mastectomy defects in 21 women with no metastases or recurrence at least one year after tumor resection. A statistically significant improvement in average breast tissue thickness at one month following treatment was reported in December at the San Antonio Breast Cancer Symposium.
The results were presented at the 9 th Japan-Korea Congress of Plastic and Reconstructive Surgery by Kaoru Kitamura, M.D., Ph.D., Department of Breast Surgery, Kyushu Central Hospital, Fukuoka, Japan. Dr. Kitamura is a co-investigator of the study with Dr. Keizo Sugimachi, M.D., Ph.D. of Kyushu Central Hospital and Masaki Mori, M.D., Ph.D., of Kyushu University.
“The investigational procedure offers hope to partial-mastectomy patients who have limited options,” said Dr. Kitamura. “Unfortunately the concept of ‘breast conserving therapy' can often times be misleading, as even minimally invasive resections can result in defects that leave patients dissatisfied with the cosmetic outcome. ”
In the study, tissue loss resulting from partial mastectomy was reconstructed with each patient's own liposuctioned fat, which was combined and enhanced with her own adipose-derived stem and regenerative cells. These cells were made available at the time of surgery using Cytori's device, the Celution 600 System.
Two clinical studies will be initiated this year in Europe by Cytori to further evaluate adipose-derived stem and regenerative cells, processed with the Celution 800 System, in breast reconstruction following partial mastectomy. One study, RESTORE II, will evaluate up to 70 patients at multiple trial sites. A second study, VENUS, will be a 20-patient single center study in patients with more severe radiation damage and contour defects.