Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced that it has recently been informed that a company-supported trial in Japan has received approval to begin enrollment from Japan MHLW (Ministry of Health, Labor and Welfare).
The ‘ADRESU’ trial is a 1-year open-label, multi-center, single arm trial to evaluate the efficacy and safety of periurethral injection of autologous adipose derived regenerative cells for the treatment of male stress urinary incontinence following prostatectomy for prostate cancer. The goal of the investigator-initiated trial will be to gain product approval for Cytori Cell Therapy technology for this indication.
The ADRESU trial will enroll 45 patients and the primary endpoint will assess the improvement in urine leakage volume from baseline by 24-hour pad test. Each patient will serve as his own control in the trial. Key secondary endpoints will include: urine leakage volume at each evaluation time point by 24-hour pad test, improvement in the number of incontinence episodes per day with greater than 50% reduction from baseline, number of incontinence episodes per day, number of pads used per day, key quality of life scores, patient overall satisfaction, key urodynamic parameters, blood flow at the injection site measured by transrectal ultrasonography and evaluation of the injection site by pelvic MRI scan.
The lead site of the trial is Nagoya University and enrollment is expected to begin in 2015 at four centers within Japan. The trial is a follow-up trial to an initial clinical study reporting positive benefits in men with urinary incontinence post-prostatectomy performed at Nagoya University (Gotoh et al. Int Journal Urology. 2014;21(3): 294-300).