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
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).