Cytori Begins Breast Reconstruction Study In Europe
Article Date: 05 May 2008 - 1:00 PDT
Cytori (NASDAQ:CYTX) received approval to begin its European stem and
regenerative cell-enhanced breast reconstruction study in breast
cancer patients who have undergone partial mastectomy. This is a post-
market study designated as RESTORE II. Currently, there is no
generally accepted reconstructive technique for partial mastectomy
patients despite the fact that breast conserving therapy is standard
practice in the treatment of women with breast cancer worldwide.
In this study, tissue loss resulting from partial mastectomy will be
reconstructed with the patients' own fat tissue (adipose), which will
be enhanced with their adipose-derived stem and regenerative cells.
This procedure is referred to as cell-enhanced reconstruction. The
cells in RESTORE II will be made available at the time of surgery
using Cytori's Celution® 800 System.
The primary goal is to obtain European reimbursement for cell-
enhanced reconstruction using the Celution® 800 System by measuring
key quality of life improvements in breast cancer patients desiring
reconstruction. Up to 70 women will be enrolled at six clinical
centers in the U.K., Italy, Spain, and France. Primary endpoints will
be patient and physician satisfaction with functional and cosmetic
outcomes at six and 12 months after surgery. Cytori's goal is to
complete enrollment before the end of March 2009.
"RESTORE II is important for advancing reconstructive options for
women with breast cancer," said Professor Emmanuel Delay, the study's
principal investigator and Chief of Plastic and Reconstructive
Surgery at The Leon Bérard Cancer Center in Lyon France. "A
successful study should broaden availability of this therapy to
partial mastectomy patients in Europe."
"Unfortunately fewer options are available to women desperate for
reconstructive surgery following partial mastectomy due to the
effects of the adjuvant radiotherapy,
surgeon at the Glasgow Royal Infirmary, and lead investigator for the
U.K. study site. "Adipose tissue enriched with stem and regenerative
cells represents a new approach that we believe allows for
predictable graft retention."
"My ongoing clinical experience using Cytori's Celution® 800 System
in breast reconstruction has been very encouraging,
Claudio Calabrese, Associate Professor of Surgery and lead
investigator at University of Florence Hospital. "The preliminary
results warrant further investigation as part of the broader, post-
market RESTORE II study."
Secondary endpoints include six and 12-month assessments of breast
volume and shape via magnetic resonance imaging (MRI) and improvement
in skin pigmentation. The study will evaluate patients who have
undergone their last breast treatment at least 12-months prior and
are recurrence free.
"The Celution® 800 System is what makes this an effective,
reproducible, bedside procedure," said Dr. Marc H. Hedrick, president
of Cytori. "Cytori has customized this system to provide a cell
output specific to breast reconstruction, to be easy to use for
doctors and hospitals, and to be affordable. We believe this mix of
attributes combined with our goal of reimbursement could fill a
tremendous patient and market need."
Fat, known medically as adipose tissue, is the body's richest known
source 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 tissue retention
compared to non-cell-enhanced tissue transfers. These results have
been confirmed in physician-initiated clinical studies.
About Cytori
Cytori's (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. The Celution® 800 System is being introduced in
Europe into the reconstructive surgery market while the Celution® 900
System will be launched in Asia-Pacific for cryopreserving a
patient's own stem and regenerative cells. Clinical trials are
ongoing in cardiovascular disease and planned for spinal disc
degeneration, gastrointestinal disorders, and other unmet medical
needs. http://www.cytoritx
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding
events, trends and business prospects, 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 regarding the collection
and results of, clinical data, dependence on third party performance,
and other risks and uncertainties described under the "Risk Factors"
in Cytori's Securities and Exchange Commission Filings. We assume no
responsibility to update or revise any forward-looking statements to
reflect events, trends or circumstances after the date they are made.
http://www.cytoritx
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StemCells subscribers may also be interested in these sites:
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http://www.CNSfoundation.org/
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http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
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