Celution™ System Wins FDA Approval; Found to Fix Breast Defects

Cytori Therapeutics, Inc. (San Diego, CA) has received FDA’s 510(k) clearance to market its Cytori Autologous Fat Transfer (AFT) System, that offers the ability to ” transfer a patient’s own adipose (fat) tissue from one part of a patient’s body to another at the point-of-care in the same surgical procedure.” We have reported about this stem cell system back in February 2006.

The company is understandably excited about the clearance, and also about a string of recent clinical accomplishments, one of which was just reported at the 30th San Antonio Breast Cancer Symposium:

The novel procedure evaluated 21 women with no metastases or recurrence at least one year after partial mastectomy. Among key findings:

The procedure was reported safe and well tolerated in all women

No rejection or immune response was observed

Patient satisfaction of the outcome was 79 percent, with a mean follow up period of 7.7 months

There was a statistically significant improvement in average breast tissue thickness at one month following treatment and at final assessment compared to baseline

There was no significant loss of tissue thickness between one month and the final assessment

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 investigational device, the Celution™ System.
“This clinical series is an exciting, early development for women with breast cancer who undergo partial mastectomy,” said Marc H. Hedrick, M.D., president for Cytori Therapeutics. “The reported data suggest this novel procedure can be safely performed, is clinically practical for surgeons to implement, and confirms Cytori’s decision to initiate clinical trials intended to establish efficacy, ascertain volume retention, and measure the magnitude of aesthetic and functional improvement.
“Reconstructive options have not kept pace with the development of new cancer therapies and existing reconstructive options for women are either ineffective, impractical or both. Until now, partial mastectomy patients have had little hope other than to live with tissue loss. This procedure holds the potential to offer women the opportunity to restore the contour, volume and function lost during cancer treatment.”
Two clinical studies will be initiated next year in Europe by Cytori to further evaluate adipose-derived stem and regenerative cells, processed with the Celution™ 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.

Cytori Therapeutics …
Press releases: Cytori Therapeutics Receives FDA 510(k) Clearance for the Cytori Fat Transfer System …; Adipose-Derived Stem Cells Show Promise in Breast Reconstruction …; Adipose-Derived Stem & Regenerative Cells Improve Fat Graft Retention in Preclinical Study …
More from the AP: Stem Cells Used to Fix Breast Defects …
Flashback: The Celution™ System