SAN DIEGO, Oct 15, 2009 (BUSINESS WIRE) -- Cytori (NASDAQ:CYTX) was informed
that stem and regenerative cells from a patient's own fat tissue were used to
treat stress urinary incontinence (SUI) as part of an investigator-initiated
five patient pilot study in Japan. The results, reported at the 7th Annual
Meeting of the International Federation for Adipose Therapeutics and Science,
suggest that the investigational treatment is safe and feasible. The study was
led by Momokazu Gotoh, MD, Ph.D., Professor and Chairman of the Department of
Urology and Tokunori Yamamoto, MD, Ph.D., Associate Professor Department of
Urology at Nagoya University Graduate School of Medicine. The cells in the study
were processed using Cytori's Celution(R) 800 System during the operative
procedure.
As part of the procedure, adipose-derived stem and regenerative cells (ADRCs)
were delivered via two distinct formulations. First, they were injected directly
into the sphincter with the goal of improving muscle contraction. Secondly,
ADRCs were combined with the patient's own fat tissue to create a cell-enriched
bulking agent with the goal to improve closure upon sphincter contraction. The
patients underwent follow-up examinations at two, four, eight, and 12 weeks and
were assessed on the basis of continence, intraurethral and leak point pressures
(measures of urethral sphincter tone), patient quality-of-life assessment, and a
variety of imaging studies. SUI in all five study patients resulted from prior
radical prostatectomy.
Dr. Yamamoto made the comment, "We confirmed that the transplanted cells
stimulate new blood supply in the treated area, stabilize the transplanted
tissue over time, and increase the urethral pressure in the majority of patients
treated. These early findings give hope to millions of patients suffering from
untreatable incontinence and the resulting impact on their quality of life.
Based on these results, we look forward to expanding the study to a larger
population of patients."
At twelve weeks following treatment, three of five patients showed improvement
in measures of leakage, urethral closure, and patient quality-of-life
assessment. These three patients were diagnosed as having severe incontinence.
Two of the five patients did not show improvement in these measures and were
diagnosed as having very severe incontinence before treatment. It is likely that
these very extreme cases, which represent the most difficult clinical challenge,
could require multiple treatments.
SUI results in the loss of one's ability to control urinary flow. Approximately
16 million patients are diagnosed with SUI each year in the United States alone.
SUI is more common in women, often as the result of childbirth, menopause or
natural aging. Among men, SUI may occur following radical prostatectomy for
prostate cancer.
About Cytori
Cytori is committed to providing patients and physicians around the world with
medical technologies, which harness the potential of adult stem and regenerative
cells from adipose tissue. With the introduction of a family of medical devices,
we have made a patient's own clinical grade stem and regenerative cells
available to them at the point-of-care. The Celution(R) System family of medical
devices and instruments is being sold into the European and Asian cosmetic and
reconstructive surgery markets, while we seek regulatory clearance for it in the
United States. Our StemSource(R) product line is sold globally for cell banking
and research applications.
Cautionary Statement Regarding Forward-Looking Statements
This communication 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 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.
SOURCE: Cytori
CONTACT:
Cytori
Tom Baker
858-875-5258
tbaker@cytoritx.com