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Enrollment Completed in ADRESU Clinical Trial of Cytori Cell Therapy for Stress Urinary Incontinence
Mar. 29, 2018 08:51AM PST
Pharmaceutical InvestingCytori Therapeutics (NASDAQ:CYTX) announced that full enrollment has been reached in the ADRESU investigator-initiated clinical trial of Cytori Cell Therapy for men with stress urinary incontinence as a complication of prostate intervention. A total of 45 patients, all treated in Japan, were enrolled in this potential approval trial. As quoted in the press release: The …
Cytori Therapeutics (NASDAQ:CYTX) announced that full enrollment has been reached in the ADRESU investigator-initiated clinical trial of Cytori Cell Therapy for men with stress urinary incontinence as a complication of prostate intervention. A total of 45 patients, all treated in Japan, were enrolled in this potential approval trial.
As quoted in the press release:
The primary endpoint for the ADRESU trial is the percentage of patients who experience greater than 50% reduction in urinary leakage volume from baseline (as measured by the weight of unintended urinary leakage over 24 hours) at 52 weeks after treatment. A number of other key secondary endpoints are also being assessed. If the primary endpoint is successfully achieved, the data may be used to seek approval of ECCI-50 for this indication.
