Determining the Feasibility of Managing Erectile Dysfunction in Humans With Placental-Derived Stem Cells.

INTRODUCTION: Stem cell therapy is thought to improve wound healing and promote vasculogenesis and has also been investigated as a treatment for patients with erectile dysfunction (ED), which is usually caused by a microvascular disease such as diabetes mellitus or hypertension.
OBJECTIVE: To determine the feasibility and effects of using placental matrix-derived mesenchymal stem cells (PM-MSCs) in the treatment of patients with ED.
METHODS: Participants were recruited from a private practice urology in Coral Springs, Florida. Each patient received an injection of PM-MSCs and was followed up with at 6 weeks, 3 months, and 6 months to assess peak systolic velocity (PSV), end diastolic velocity, stretched penile length, penile width, and erectile function status based on the International Index of Erectile Function questionnaire.
RESULTS: Eight patients were injected with PM-MSCs. At the 6-week follow-up, PSV ranged from 25.5 cm/s to 56.5 cm/s; at 3 months, PSV ranged from 32.5 cm/s to 66.7 cm/s. Using unpaired t tests, the increase in PSV was statistically significant (P<.05). At 6 months, PSV ranged from 50.7 cm/s to 73.9 cm/s (P<.01). Changes in measured end diastolic velocity, stretched penile length, penile width, and International Index of Erectile Function scores were not statistically significant. At the 6-week follow-up, 2 patients for whom previous oral therapies failed had the ability to sustain erections on their own. At the 3-month follow-up, 1 additional patient was able to achieve erections on his own.
CONCLUSION: To our knowledge, this is one of the first human studies to report on the feasibility of using stem cell therapy to treat patients with ED. The results indicate that this treatment may be beneficial, and further investigations with larger sample sizes should be conducted. (ClinicalTrials.gov number NCT02398370).