Cytori Therapeutics has completed enrolment in the ADRESU clinical trial, an investigator-initiated study evaluating Cytori Cell Therapy for the treatment of men with stress urinary incontinence as a complication of prostate intervention.
Cytori Cell Therapy is an ECCI-50 cellular therapeutic that comprises Celution-prepared autologous Adipose Derived Regenerative Cells (ADRCs) and Adipose Cells.
The open-label, single arm trial has enrolled a total of 45 patients, who were treated in Japan.
The trial’s primary objective is the percentage of patients who experience a 50% or more reduction in urinary leakage volume from baseline, as measured by the weight of unintended urinary leakage over 24 hours, at 52 weeks after treatment.
The trial, which is led by Nagoya University Department of Urology professor and chairman Dr Momokazu Gotoh, also includes a number of other key secondary endpoints.
Depending upon the success of the trial, Cytori plans to use the study results to seek approval of ECCI-50 for male stress urinary incontinence, a post-surgical complication of radical prostatectomy and surgeries for benign prostatic hyperplasia.
Cytori Therapeutics president and CEO Dr Marc Hedrick said: “Cytori would like to thank the investigators and patients participating across the four sites involved in this clinical trial: Nagoya University, Shinshu University, Kanazawa University and Dokkyo University.
“If the trial successfully meets key endpoints, Cytori intends to seek marketing approval and reimbursement for this cellular therapeutic product in Japan.”
A large chunk of costs of the ADRESU trial has been provided by the Government of Japan unit Japan Agency for Medical Research and Development.
Cytori has also provided additional support to the trial, which is sponsored by Japan’s Nagoya University.