Adipose-Derived Stem Cells Show Promise in Breast Reconstruction
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(TM) 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(TM) 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.
Fat, known medically as adipose tissue, is one of the body's richest and most accessible sources of regenerative cells. Adipose-derived regenerative cells include adult stem cells in addition to other important cell types that have been shown pre-clinically to improve volume retention and graft persistence. For this reason, these cells potentially may improve and simplify traditionally complex fat transfer procedures as well as enable more predictable outcomes when applied to cosmetic and reconstructive surgery.
More than one million women worldwide are diagnosed with breast cancer annually, including more than 370,000 women in Europe and more than 240,000 in the United States. Due to continual advancements in cancer detection, a growing percentage of women are eligible for partial versus full mastectomies. Unfortunately, partial mastectomy often results in significant skin damage, tissue loss, pain, and reduction or loss of motion. Women who undergo such procedures have limited reconstructive options to potentially reduce associated pain, reverse loss of motion, and restore breast volume and contour.
Cytori Therapeutics' (NASDAQ:CYTX) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients' adult stem and regenerative cells. To reach its goal, Cytori is developing its innovative Celution(TM) System to separate and concentrate a patient's own adult stem and regenerative cells from adipose (fat) tissue for these cells to be delivered back to the patient during the same surgical procedure. The Celution(TM) System will be introduced in 2008 in Europe for reconstructive surgery and launched in Japan for cryopreserving a patient's own stem and regenerative cells. Clinical trials are ongoing or planned in cardiovascular disease, spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. www.cytoritx.com
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and prospects of our business, which may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, regulatory uncertainties, dependence on performance of third parties, and other risks and uncertainties described (under the heading "Risk Factors") in Cytori Therapeutics' Form 10-K annual report for the year ended December 31, 2006. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
Tom Baker, 858-875-5258
Posted: December 2007