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 that patient satisfaction remained at 79%, with a mean follow-up of 12-months, and 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.
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.