Stem cell therapy outcome for diabetic erectile dysfunction: A pilot analysis

Abstract

Background Many males encounter the condition of erectile dysfunction (ED), particularly individuals diagnosed with type 2 diabetes mellitus (DM). Stem cell therapy is a burgeoning treatment modality being explored for individuals with erectile dysfunction in the context of type 2 DM. Nevertheless, the available body of clinical evidence supporting its efficacy remains limited. This study aims to assess the effectiveness and safety of umbilical cord-derived mesenchymal stem cell (MSC) therapy in managing erectile dysfunction (ED) resulting from type 2 DM. Methods A randomized, double-blind, placebo-controlled trial was conducted at Dr. Cipto Mangunkusumo Hospital in Indonesia from October 2020 to January 2023. A total of 26 eligible patients were randomly assigned to two groups: one receiving intracavernosal injections of MSC and the other receiving a placebo. Follow-up assessments were conducted at baseline, month one, and month three. The primary outcomes were measured using the IIEF-5 questionnaire and dorsal artery peak systolic velocity (PSV). Metabolic markers were used as secondary outcomes. Results The IIEF-5 scores for both groups showed a significant increase (p < 0.001) from baseline to month three. There was no significant difference observed between the MSC and placebo groups. Moreover, no significant differences were observed in the PSV of the dorsal artery between the two groups (p>0.05). There were no significant differences in metabolic markers between the groups. The incidence of mild post-injection pain was reported by only 11% of individuals, indicating a low occurrence of adverse events. Conclusions Intracavernous administration of MSC did not demonstrate superior efficacy compared to a placebo in improving metabolic or erectile function in diabetic males with erectile dysfunction. Additional research utilizing larger sample sizes and more extended follow-up periods is necessary.