Intracavernous injection of stem cell-derived bioactive molecules for erectile dysfunction—a pilot phase non-randomized controlled trial

Background and objective: Experimental and few clinical studies have indicated great potential of stem cell treatments as both a causal and symptomatic approach for the treatment of male erectile dysfunction (ED). We investigated the effect of a one-time injection of stem-cell derived bioactive molecules in patients with self-reported ED. Materials and methods: Twenty self-referred male patients with at least one-year history of ED received a one-time intra-penile injection of acellular stem cell-derived bioactive molecules. ED was evaluated by the International Index of Erectile Function questionnaire (IIEF-5), and quality of life was assessed by the Short-Form-36 questionnaire, (SF-36) at baseline and at 6 months. Six male patients with ED, who received a similar injection using saline served as a historic control. Primary outcome was erectile function as measured by IIEF-5 scores. Secondary outcomes were quality of life, assessed by SF-36 questionnaire. Results: IIEF-5 scores improved from 12.9 ± 4.47 at baseline to 18 ± 3.37 at follow-up (p < 0.05). No significant difference of IIEF-5 scores were observed in the historic controls during the observation period (11 ± 2.53 at baseline vs 10.67 ± 3.5 at follow-up; p > 0.05). Patients, who received stem cell injections, demonstrated significantly enhanced IIEF-5 scores compared to the historic control (p < 0.05). Quality of life scores were significantly improved (role limitations due to physical health issues 56.25 ± 42.82 at baseline vs 68.75 ± 40.45 at follow-up, p < 0.05, energy 51.57 ± 19.33 at baseline vs 57.75 ± 12.3 at follow-up, p < 0.05, emotional wellbeing 56.32 ± 16.28 at baseline vs 68.1 ± 11.73 at follow-up, p < 0.05, and social functioning 67.5 ± 23.79 at baseline vs 76.25 ± 18.98 at follow-up, p < 0.05). Conclusions: A one-time intracavernous acellular stem cell-derived bioactive molecule injection improves IIEF-5 scores and quality of life in men with ED in this small pilot phase study (ClinicalTrials.gov Identifier: NCT04684602).