The phase I erectile dysfunction trial of Cytori Therapeutics' Cytori Cell Therapy was found to be safe and potentially effective in the European Union.
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Cytori Therapeutics carried out the open-label, single-arm study in Denmark on 17 patients who had undergone radical prostatectomy within 5-18 months before the trial.
A single intracavernous injection of Cytori Cell Therapy was given to all patients and the company said there were no severe adverse effects reported at six months follow-up.
Eight of the 17 subjects recovered erectile function within three months of treatment and a post-hoc analysis was carried out in which patients were divided into those who were continent before treatment and those who were incontinent.
Of the 11 in the continent group, eight recovered erectile function which remained improved at six months. None of the six incontinent patients recovered function.
Cytori Cell Therapy is also being studied in the Adresu trial in Japan for male urinary incontinence after prostatic surgery.
Cytori Therapeutics president and CEO Marc Hedrick said: "This recent Danish trial coupled with the ADRESU incontinence trial and related clinical experience in Japan , provide evidence that Cytori Cell Therapy may be able to effectively target two common and important side effects of prostate surgery, incontinence and erectile dysfunction.
"In the future, data from these trials may provide a foundation for broader clinical use of our technology for other urologic diseases."
Data from preclinical trails and clinical studies indicate that Cytori Cell Therapy acts principally by enhancing blood flow, changing the immune system, and facilitating wound repair.