Adipose-Derived Stem Cells Show Promise in Breast Reconstruction
Cytori Therapeutics (NASDAQ:CYTX) received results from an
independent, investigator-sponsored study in Japan in which adipose
tissue-derived stem and regenerative cells were used for breast
reconstruction following partial mastectomy. The study data were
presented today at the 30th San Antonio Breast Cancer Symposium
(Poster #4071).
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
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
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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.