A one time injection of stem cells into the penis has restored function in some men after undergoing prostate removal surgery, even if they had previously not responded to conventional drugs including Viagra, as published in the journal Urology.
Radical prostatectomy can carries some side effects the most common being erectile dysfunction and urinary stress incontinence, some patients can be treated but a sizable portion will receive no benefits from conventional drug therapies. Much anecdotal reports have been generated regarding stem cell therapy as being of benefit, but clinical evidence was somewhat lacking.
Cytori and its Denmark investors have provided clinical support via an open label phase 1 trial of adipose derived regenerative cells in 21 patients which included 15 patients who were urinary continent after surgery and 6 patients who were incontinent after surgery.
Adipose derived regenerative cells therapy based on the International Index of Erectile Function-5 efficacy scale achieved improvement in overall sexual function, but was not able to hit target on an accompanying erection hardness score measure, but there may be an explanation for the result coming down to how badly the men were affected after the surgery.
A 15 patient subset didn’t develop urinary incontinence after surgery did much better on the International Index of Erectile Function-5 efficacy scale measure as well as the accompanying erection hardness score measure, among that group 53% recovered enough erectile function to be able to have intercourse during the period of the 12 month study.
Findings serve to throw out a lifeline of sorts to men who are not able to resolve their erectile dysfunction with oral drugs such as Cialis and Viagra which are PDE5 inhibitors, or with direct prostaglandin based drugs injected directly into the penis. When these options fail, typically the last resort is a penile implant, this study suggests that there another option before that last resort.
Erectile dysfunction drug treatments represent a rather huge market that is estimated to be around $5 billion. Generic competition is chipping away at branded product sales, now a one off stem cell therapy can offer up another intriguing option and opportunity.
Previous to this there are some private clinics around the world that have been offering erectile dysfunction treatments without clinical data regarding safety and efficacy according to Martha Haahr Ph.D.
This 12 month data reinforces 6 months of results in 17 subject reported during 2016, but that study was limited by not being blind, meaning that placebo effect can’t be ruled out or possibility of the improvements happening spontaneously over time, according to the researchers.
Next phase before this adipose derived regenerative stem cell therapy can be made available is to perform a randomized blinded placebo controlled trial among continent men. Overall this was seen as a positive trial which comes just as biotech is about to carry out another trial to see if adipose derived regenerative stem cells can tackle urinary stress incontinence after radical prostatectomy.
