Enrollment Completed In Trial Of Treatment For Stress Urinary Incontinence.
SAN DIEGO, Calif., March 28, 2018 -- Cytori Therapeutics, Inc. (CYTX) said the ADRESU investigator-initiated clinical trial of Cytori Cell Therapy for men with stress urinary incontinence as a complication of prostate intervention has completed enrollment.
A total of 45 patients, all treated in Japan, were enrolled in this potential approval trial.
ADRESU is an investigator-initiated, multicenter, open-label, single arm clinical trial of Cytori's ECCI-50 cellular therapeutic, comprised of Celution-prepared autologous Adipose Derived Regenerative Cells (ADRCs) and adipose cells.
The ADRESU trial was based on a promising pilot trial with short-term data of 11 patients published in the International Journal of Urology in 2014 and long-term data of 14 patients presented at the International Continence Society in 2017, that "demonstrated that transurethral injection of autologous can be a safe and effective treatment modality for postprostatectomy incontinence."
The primary endpoint for the ADRESU trial is the percentage of patients who experience greater than 50 reduction 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 end- points are also being assessed. If the primary end-point is successfully achieved, the data may be used to seek approval of ECCI-50 for this indication.
Male stress urinary incontinence is a post-surgical complication of radical prostatectomy and surgeries for benign prostatic hyperplasia with limited treatment options, representing an unmet medical need.
Cytori Cell Therapy is a suspension of ADRCs that are manufactured from a single lipoaspirate (material removed via liposuction, a procedure in which fat is removed from under the skin by suction). The process concentrates ADRCs intended for autologous re-implantation subcutaneously into the digits.
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|Title Annotation:||Clinical Trials|
|Publication:||Stem Cell Business News|
|Date:||Apr 2, 2018|
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