The results of phase 1 of the erectile dysfunction clinical trials of Cytori Therapeutics new Cyton Cell therapy are in. The good news is that it has been found to be both safe and potentially effective where the studies took place in the European Union.
President and CEO of Cytori Therapeutics Mark Hendrick expressed that the results in Denmark in combination with the Adresu trials in Japan can now provide much needed evidence that the Cytori Cell Therapy treatment can provide answers and effectively target two common problems that are typically associated with prostate surgery. The problem of incontinence and erectile dysfunction
Who were the participants
The trial was a single arm, open-label study and the testing was carried out by Cytori Therapeutics In Denmark. Participants in the study consisted of 17 patients. These patients were chosen because in as little as five months but not longer than eighteen months prior to the trial they had undergone radical prostatectomy procedures.
What the study entailed
Patients in the study were given an intravenous, single injection of the Cytori Cell Therapy.
- No adverse effects reported or observed after following up at six months.
- Of the seventeen patients observed, eight of them were able to recover erectile function in less than three months after the initial treatment.
- Subjects in the trial were also divided into two further groups, those who were incontinent and those who were not.
- Post hoc observation and analysis revealed that that most of the subjects that were continent, recovered erectile function and continuously improved with no adverse effect up to 6 months
- In fact 11 subjects recovered erectile function.
- Among the six patients who were incontinent before the trials, none of them recovered erectile function.
The Cytori Cell Therapy is also being looked at as a treatment option in Japan in the Adresu Trials, to address the problems associated with incontinence among males after prostate surgery.
The results from the Cytori Cell Therapy Trials and the Adresu Trials in Japan provide evidence of the success of these type of therapies to address these issues without surgery. The treatment utilized the body’s immune system to improve its functioning by enhancing blood flow in order to promote, facilitate and enhance repairs to the damages experienced as a result of the prostate surgery.
The results are welcome and very good news as It can also form the foundation or basis for other clinical uses of the treatment and for other studies or trials to be done as well as technological advances to treat other Urologic conditions.