Presentation Authors: Dalsan You*, Myoung Jin Jang, Seoul, Korea, Republic of, Geehyun Song, Chuncheon, Korea, Republic of, Ha Chul Shin, Seongnam, Korea, Republic of, Nayoung Suh, Asan, Korea, Republic of, Yong Man Kim, Seongnam, Korea, Republic of, Tai Young Ahn, Choung-Soo Kim, Seoul, Korea, Republic of
Introduction: The efficacy of phosphodiesterase type 5 inhibitors (PDE5I), which are commonly used to treat erectile dysfunction (ED), is not satisfactory in patients with diabetes mellitus and denervation of the cavernous nerve due to pelvic surgeries. Preclinical studies using bone marrow-derived mesenchymal stem cells (BMSCs) to treat ED have shown promising results. We conducted a phase 1 clinical trial with autologous BMSCs in patients with ED due to DM or radical prostatectomy.
Methods: Ten patients (five postprostatectomy ED; five DM-associated ED) in whom the erectile function was unlikely to recover with PDE5I, were enrolled. The brief study protocol was registered at the ClinicalTrials.gov site of the US National Institutes of Health (#NCT02344849, Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Erectile Dysfunction). The primary outcome was the safety of stem cell therapy while the secondary outcome was the improvement of erectile function.
Results: One patient in the postprostatectomy ED experienced two treatment-emergent adverse events (TEAEs) (pyrexia, back pain), and two in the DM-associated ED experienced a total of five TEAEs (viral upper respiratory tract infection, prostatitis, pruritus, two hyperglycemia). Of them, one patient in the DM-associated ED experienced two serious TEAEs (two hyperglycemia). All TEAEs were considered as not related to study drug. In addition, no clinical significance was observed in other safety measuress such as laboratory tests and vital signs. Mean International Index of Erectile Function score increased significantly at 30 days versus baseline (24.9 vs 18.1; P=0.0222).
Conclusions: This phase 1 clinical trial confirmed the safety and potential efficacy of autologous BMSCs therapy in patients with ED. Our results need to be confirmed by phase 2 clinical trial.
Source of Funding: This study was supported by Pharmicell Co. Ltd..