Scientists have investigated stem cell therapy for the treatment of erectile dysfunction (ED), but few studies have focused on human subjects. A recent review paper in Sexual Medicine Reviews discusses human trials and stresses the need for more research.
Stem cell therapy, along with shockwave therapy and injectable platelet-rich plasma, is a restorative approach. Its goal is to “reverse the underlying changes that have caused the patient’s ED,” the study authors explained. Other clinical areas investigating stem cell therapy include cardiology, neurology, and orthopedics.
However, stem cell therapy is currently not a routinely recommended ED treatment and it is not approved by the U.S. Food and Drug Administration)(FDA). The American Urological Association (AUA), the European Association of Urology (EAU), and the Sexual Medicine Society of North America (SMSNA) consider the approach investigational. [Note: The SMSNA is affiliated with the International Society for Sexual Medicine (ISSM)]
The researchers analyzed five clinical trials of stem cell therapy in men with ED that were published between 2010 and 2018. Overall, 61 men between the ages of 50 and 70 were involved. Several types of stem cell therapy were used, including mesenchymal stem cells and stromal vascular fractions.
The studies evaluated the safety, tolerability, and efficacy of stem cell therapy over follow-up periods that ranged from 6 to 60 months. In particular, researchers used the International Index of Erectile Function (IIEF), the Erection Hardness Scale, and penile vascular flow measurements as assessment tools.
In general, the studies reported improvements in erectile function with no serious adverse events. Harvesting and injection of stem cells were well-tolerated, according to the two studies that concentrated on this factor.
The trial results “seem promising,” the authors wrote, but several limitations were noted. For example, none of the studies had large numbers of participants. In addition, the trials focused on the safety and tolerability of stem cell therapy, not changes in erectile function. The studies also used stem cells from various sources, and there isn’t yet enough data to generalize results.
“Ultimately, all 5 of the studies concluded that further research must be done on [stem cell therapy] for ED before it can become a routinely offered treatment modality,” the researchers said. They recommended long-term studies along with research in men with prostate cancer, as stem cells could promote the growth of prostate cancer cells.
“[Stem cell therapy] may be a paradigm shift in the treatment of ED, however, more data and research must be conducted to prove its efficacy and safety,” the authors concluded.
Sexual Medicine Reviews
Lokeshwar, Soum D., et al.
“A Systematic Review of Human Trials Using Stem Cell Therapy for Erectile Dysfunction”
(Full-text. Published online: October 19, 2019)