Stem cell therapy in diabetic men with erectile dysfunction: a 24-month follow-up of safety and efficacy of two intracavernous autologous bone marrow derived mesenchymal stem cells injections, an open label phase 2 clinical trial

Affiliations

PMID: 38965462

PMCID: PMC11225209

DOI: 10.1186/s12610-024-00229-y

BACKGROUND Recently we reported the results of the phase 1 pilot clinical trial of 2 consecutive intracavernous (IC) injections of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) for the first time in the treatment of diabetic patients with erectile dysfunction (DM-ED). In phase 2 of this study, we aim to evaluate long-term safety and efficacy of IC injections of BM-MSC on additional eight patients with DM-ED.

Results: Each patient received 2 consecutive IC injections of BM-MSC and was evaluated at 1, 3, 6, 12, and 24-month time points. The primary outcome was the tolerability and safety of stem cells therapy (SCT), while the secondary outcome was an improvement of erectile function (EF) as assessed using the International Index of Erectile Function-5 (IIEF-5), Erection Hardness Score (EHS) questionnaires, and Color Duplex Doppler Ultrasound (CDDU). IC injections of BM-MSCs were safe and well-tolerated. Minor local and short-term adverse events related to bone marrow aspiration and IC injections were observed and treated conservatively. There were significant improvements in mean IIEF-5, EHS, all over the follow-up time points in comparison to the baseline. At 24-month follow up there was a significant decline in the mean IIEF-5, and EHS compared to the baseline. The mean basal and 20-min peak systolic velocity was significantly higher at 3-month after the IC injections compared to baseline.

Conclusions: This phase 2 clinical trial confirmed that IC injections of BM-MSC are safe and improve EF. The decline in EF over time suggests a need for assessing repeated injections.