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SAN DIEGO--(BUSINESS WIRE)--Cytori (NASDAQ:CYTX - News) 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® 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
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Rekrutierung eingestellt! 11.11.09
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy (RESTORE-2)
This study is ongoing, but not recruiting participants.
First Received: February 5, 2008 Last Updated: November 11, 2009 History of Changes
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Further study details as provided by Cytori Therapeutics:
Primary Outcome Measures:
•Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
•Change in breast volume and shape at 6 and 12 Months compared to baseline. Improvement in skin pigmentation abnormalities at 6 and 12 months compared to Baseline. Improvement in overall breast deformity at 6 Months compared to Baseline. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 70
Study Start Date: June 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
Procedure: ADRC-Enhanced Autologous Fat Transplant
Autologous fat harvested from the patient is enhanced with ADRCs derived from a portion of the harvested fat and transplanted into the breast(s) that have a volume deficit post lumpectomy. This is a single arm study with no control. All patients receive cell therapy.
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