Login to Access Video or Poster Abstract: MP41-17
Sources of Funding: None

Introduction

Cell- and tissue-based therapeutic approaches are progressively gaining ground in the clinics. Evidence from animal models replicating post radical prostatectomy (RP) erectile dysfunction (ED) suggests intracavernous injection of stem cells as a promising treatment approach for ED. We report result from a phase 1 trial with autologous adipose derived regenerative stem cells (ADRCs) used freshly isolated after liposuction.

Methods

21 men with ED after RP, performed 6-17 months prior were enrolled in this prospective phase 1 open label and single-arm study. All men tried full pharmacological intervention (PDE-5 or PGE1 analog) with insufficient effect prior to inclusion. The primary objective was to assess the safety of ADRC and secondary recovery of erectile function. Each patient received one treatment and was seen 1,3,6 and 12 months after the intracavernosal ADRCs transplantation. Erectile function was assessed by IIEF and EHS scores. Adipose tissue collection was performed with water-jet-assisted liposuction during general anesthesia. Following immediate isolation of ADRCs, using an automated processing Celution 800/CRS system, these were injected into corpus cavernosum. The Danish Health and Medicines Authority and Ethical Committee approval has been obtained.

Results

Overall, 8 of 14 (57%) continent men recovered their erectile function, and could implement sexual intercourse after 6 months and the effect sustained 12 months after stem cell treatment. Post-hoc stratification according to content/incontinent status was performed. Efficacy was solely demonstrated in the patients that were continent at inclusion. Accordingly, in continent men IIEF-5 score was unchanged one month after the treatment 6 (4) (median (IQR) (mean 8.5 (95% CI 5.26-11.3)) RM one-way ANOVA with Sidaks' multiple comparisons test), but significantly increased after 6 months to 11 (17) (14.27 (9.834 to 18.70), p< 0.001) and at 12 months (9 (20) (13.2 (8.833-17.57), p< 0.05). In contrast, incontinent men did not regain erectile function (median IIEF-5 6 months= 5 (1) 5.33 (95% CI 4.791-5.875)). No serious adverse events but 8 minor events related to the liposuction were reported._x000D_

Conclusions

Freshly isolated autologous ADRCs statistically significantly improved erectile function in continent men. No serious adverse events were recorded after injection or during follow-up. We suggest that ADRCs represent a promising novel interventional therapy of ED following RP.

Funding

None