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, Nagoya University Graduate School of Medicine.
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 2, 4, 8, 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 12 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.
Illustration: Urinary tract system. Wikipedia.
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