Adipose-Derived Stem and Regenerative Cells Show Potential in First-in-Man Treatment of Stress Urinary Incontinence

October 15, 2009 9:59 PM EDT

SAN DIEGO--(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

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