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Cytori Cell Therapy Safe and Potentially Effective in EU Phase I Erectile Dysfunction Trial
Cytori Therapeutics, Inc. (NASDAQ:CYTX) published the results of an investigator initiated Phase I clinical trial using Cytori Cell Therapy™ for the treatment of erectile dysfunction (ED) following radical prostatectomy (RP).
Cytori Therapeutics, Inc. (NASDAQ:CYTX) published the results of an investigator initiated Phase I clinical trial using Cytori Cell Therapy™ for the treatment of erectile dysfunction (ED) following radical prostatectomy (RP).
According to the company’s release:
The open-label, single-arm study was conducted in Denmark and enrolled 17 patients who had undergone radical prostatectomy within 5-18 months prior to the study. To qualify for the study, patients were required to have not regained erectile function following surgery despite appropriate pharmacological intervention. All patients received a single intracavernous injection of Cytori Cell Therapy. There were no serious adverse effects reported at six months follow-up, and eight of the 17 patients recovered erectile function within three months of treatment. In the publication, the authors concluded their “…findings suggest that autologous, freshly isolated ADRCs are safe to use and possess potential efficacy in the treatment of ED after RP.”
Dr. Martha Haahr, the lead investigator, stated:
We are very pleased with the results from our Phase 1 study. In this open-label trial, we saw a very good effect on erectile function. It is remarkable, especially as these men had previously seen no effect from traditional medical treatment and continue to have good erectile function after 6 months follow-up. This suggests the possibility of therapeutic options for patients suffering from erectile dysfunction from other causes. We are already planning a double-blind randomized follow-up study.
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