For some men with prostate cancer, surgery to remove the prostate gland can be curative. The surgery to remove the entire prostate gland, called radical prostatectomy, can improve survival. If performed early, radical prostatectomy can prevent metastatic prostate cancer. While men who qualify for this surgery often jump at a chance to cure prostate cancer, radical prostatectomy comes with a price—it almost always causes erectile dysfunction.
Even under the best surgical conditions, most men experience at least temporary erectile dysfunction after radical prostatectomy. While some men can regain erectile function by using oral ED treatments, as many as 3 out of 5 men continue to have poor erections and/or difficulty with orgasm months to years after radical prostatectomy.
In an attempt to find a way to treat this serious issue, researchers in France conducted a clinical trial to test whether mononuclear cells treatment could improve erectile function in men who had undergone radical prostatectomy and developed erectile dysfunction (INSTIN, INtra-cavernous STem-cell INjection clinical trial, NCT01089387). Mononuclear cells are a type of stem cell that can become many other cells, including nerve or blood vessels cells. The researchers collected mononuclear cells from the bone marrow of affected men and injected these cells into the patient’s own penile tissue (i.e. autologous stem cell infusion). The researchers then followed the men for 6 to 12 months to track whether the mononuclear cells helped improve erectile function.
The first phase of the phase 1/2 clinical trial was designed to assess the safety of the treatment. No patients in the trial experienced any side effects from treatment. Likewise, prostate cancer did not return any of the men within one year after treatment (and perhaps longer, the men were only followed for one year at the time of the report).
Within six months of treatment, men treated with the bone marrow stem cells had a significantly better erectile function and satisfaction with sexual intercourse. While the benefit was still present after the 12 months, the erectile function was not quite as good as it was at six months after treatment. This suggests injections may need to be repeated every six months to maintain maximal benefit.
These results are incredibly encouraging for men with erectile dysfunction caused by radical prostatectomy. While future clinical trials should contain a control group and larger numbers of men, these phase 1/2 clinical trial results pave the way for such research. These findings also suggest men who have life-saving prostate cancer surgery may be able to regain erectile function after surgery through stem cell treatment.
Reference: Yiou, R. et al. (2017). Intracavernous Injections of Bone Marrow Mononucleated Cells for Postradical Prostatectomy Erectile Dysfunction: Final Results of the INSTIN Clinical Trial. European Urology Focus. 2017 Dec;3(6):643-645.
Prostate cancer is quite common among men in the United States. The main treatment options for prostate cancer include:
- External beam radiation – Radiation is applied to the prostate gland through the skin (noninvasive)
- Brachytherapy – Radioactive pellets the size of grains of rice are placed within the prostate gland (invasive)
- Radical prostatectomy – The entire prostate gland and some surrounding tissue is removed
About one-quarter of all men with prostate cancer ultimately choose to have a radical prostatectomy. Unfortunately, this procedure often leaves men with chronic problems afterward, such as urinary incontinence (i.e., the inability to hold or control urine) and erectile dysfunction (i.e., the inability to achieve and maintain a penile erection suitable for sexual intercourse). Almost 90% of men who undergo radical prostatectomy to treat prostate cancer develop erectile dysfunction. Drugs and penile injections are not always effective in treating this type of erectile dysfunction. Consequently, as many as three-quarters of men must live with permanent erectile dysfunction. While prostate cancer is essentially cured after radical prostatectomy, affected men have substantially worse quality of life, which also negatively affects their sexual partners.
In an effort to combat this difficult problem, researchers conducted a Phase 1 clinical trial in which they took stem cells from the patient’s own fat tissue (autologous stem cells), purified them, and injected them into the penile tissue of radical prostatectomy patients with erectile dysfunction. Eight of the 17 men who volunteered for the clinical trial regained erectile function and were able to engage in sexual intercourse after just one stem cell injection.
Importantly, stem cell treatment was only effective for men who had not developed urinary incontinence. Eight of 11 men who still could control their urine after radical prostatectomy regained their ability to achieve and maintain erections. Conversely, no man with urinary incontinence after radical prostatectomy had erectile function restored.
The researchers noted that the stem cell treatment was very well tolerated by all men, and described the procedure as safe.
While larger clinical trials are needed to confirm these results, autologous stem cells taken from a patient’s own fat tissue were able to restore erectile function in most of the men treated. This research suggests that men who do not lose urinary function may benefit from this procedure. On the other hand, men who become incontinent after radical prostatectomy may not benefit from this particular stem cell therapy. Randomized, placebo-controlled clinical trials will help clarify this issue. In the meantime, these results are encouraging news to thousands of men who suffer from permanent erectile dysfunction as a result of their radical prostatectomies.
Reference: Haahr, MK et al. (2016). Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial. EBioMedicine. 2016 Jan 19;5:204-10.
The little blue pill brought erectile dysfunction from out of the shadows and into our shared awareness. Erectile dysfunction affects millions of men and, in turn, their sexual partners. The condition can undermine a man’s sense of self-worth, self-esteem, and masculinity. While the little blue pill has been instrumental in getting men with erectile dysfunction to ask their doctors about treatment, that same pill does not work for every man. Indeed, countless men fail to achieve successful erections even after taking oral erectile dysfunction medication.
In one of the first clinical studies of its kind, urologists at a medical practice in Florida tested the effects of mesenchymal stem cell treatments in men with erectile dysfunction. They selected eight men with erectile dysfunction who could not achieve erections even after oral medications. The men received mesenchymal stem cells that were derived from human placenta (also known as afterbirth). The urologists then followed the men for six months after treatment, testing blood flow, penile size, and erectile function.
The men treated with mesenchymal stem cells had a statistically significant increase in penile blood flow at six weeks, three months, and six months after treatment. Three men were able to achieve erections within three months of treatment without oral erectile dysfunction medication. After stem cell treatment, four other men were able to achieve erections with low-dose oral erectile dysfunction medication (which had previously been ineffective).
Importantly, the treatment was well-tolerated by all men in the study, which is an important milestone for continuing this research.
The study is potentially groundbreaking as it opens the door to larger clinical studies in men with erectile dysfunction. Indeed, nearly two dozen clinical trials are now studying the effects of stem cell treatment for erectile dysfunction. These early results are exciting, and offer hope to men with erectile dysfunction, especially those for whom oral medications have failed.
Reference: Levy, JA (2016). Determining the Feasibility of Managing Erectile Dysfunction in Humans With Placental-Derived Stem Cells. The Journal of the American Osteopathic Association. 2016 Jan;116(1):e1-5.