Pressemitteilung BoxID: 234848 (Cytori Therapeutics, Inc.)
  • Cytori Therapeutics, Inc.
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First Patient Treated in Adipose Stem & Regenerative Cell Study for Stress Urinary Incontinence

(PresseBox) (Nagoya, Japan, ) Cytori (NASDAQ: CYTX) announced that the first patient was enrolled in an investigator-initiated safety and feasibility study using adipose-derived stem and regenerative cells to treat stress urinary incontinence. The 10-patient study is being conducted independently by Nagoya University Hospital in Japan. Cytori's Celution(R) 800 System is being used to process and extract the patients' own adipose tissue-derived stem and regenerative cells at the time of surgery.

"The Celution System is uniquely able to provide real-time access to clinical grade stem and regenerative cells to meet the growing demand Cytori is seeing from physicians seeking regenerative medicine-based treatments," said Seijiro Shirahama, President, Cytori Asia Pacific. "As a result, hospitals are increasingly interested in a Celution purchase to fill this need in the marketplace. This demand is partially reflected in the seven investigator-initiated clinical studies taking place in Japan which use the Celution System."

As part of the study, stem cells were injected intra-muscularly into the sphincter as well as in combination with a measured volume of the patient's own fat tissue to create a bulking agent to support the urethra. The study will evaluate safety, functional endpoints including intraurethral pressure and leak point pressure, as well as subjective assessments of patient and physician satisfaction. Current treatments include use of collagen as a bulking agent to provide pressure against and support the urethra.

"There are a growing number of scientific publications that show adipose derived stem and regenerative cells can ameliorate urinary incontinence," said Momokazu Gotoh, M.D., Ph.D., Professor and Chairman, Department of Urology, Nagoya University Graduate School of Medicine. "Celution is the only feasible way to derive the cells in a clinically practical manner. This first case could not have gone better and the Celution System performed flawlessly."

Stress urinary incontinence can have a significant impact on a patient's quality of life, resulting in involuntary release of urine due a weakened urethral sphincter. The condition is more common in women and often comes about following child birth or menopause. It is estimated that approximately 9 million people in Japan, and more than 13 million women in the U.S., are affected by stress urinary incontinence.

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.

Cytori Therapeutics, Inc.

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(R) 800 System is being introduced in Europe into the reconstructive surgery market while the Celution(R) 900 System is being commercialized globally 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.