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    • Additionally urinary incontinence scores ICIQ UI SF were sig

    2018-11-05

    Additionally, urinary incontinence scores (ICIQ-UI SF) were significantly lower 6months after ADRC injection in continent men 0 (Dohner et al., 2015) (median (IQR))(p=0.0234, Wilcoxon matched pairs signed rank test) as compared to inclusion 3 (Tal et al., 2009) and a trend (8 (9) versus 12.5 (10.25)(p=0.1875) was seen in incontinent men as well (Supplemental Fig. S2), suggesting that ADRC treatment may also have a positive effect on incontinence per se.
    Discussion In this clinical trial autologous non-expanded stem norepinephrine bitartrate have been used for the treatment of ED following radical prostatectomy. In recent years, much attention has been given to stem cell-based therapies in general, and specifically in the field of urology where there has been a great deal of hype in relation to treatment of erectile dysfunction (ED) (Khera et al., 2015). Until now, there has been only one other published clinical trial reporting a beneficial effect of non-autologous umbilical cord cell transplantation in 3/7 men with type 2 DM (Bahk et al., 2010). Earlier this year, this lack of substantial evidence from clinical trials led to a commentary in which Khera et al. raised their concerns regarding stem cell treatment of ED patients outside an approved protocol (Khera et al., 2015). In this study, a single intracavernous injection of freshly isolated autologous ADRCs was a feasible, safe and well-tolerated approach for treating ED following radical prostatectomy. We did not observe any serious adverse events within a 6-month time frame, which – while clearly not sufficient for a long-term safety evaluation – nevertheless is reassuring. The safety from clinical trials encompassing more than 1000 patients receiving bone marrow or adipose tissue-derived mesenchymal stem/stromal cells, does not suggest that serious adverse events is a clinically important issue (Casiraghi et al., 2013). Importantly, post-hoc stratification demonstrated that the majority of continent men with ED after RP recovered erectile function within 3months, and that this effect persisted for 6months. This potential efficacy of the ADRC therapy was promisingly high, reaching 8/11 (73%). In contrast, such effect was absent in the group of incontinent men. These different outcomes are unlikely to result from underlying differences in the amount of injected stem cells or in their phenotypes, since all analyzed parameters were statistically equal between groups. However, the incontinent men may represent individuals where damage to the neurovascular bundle has resulted in partial disruption of urethral rhabdosphincter innervation as reported recently (Reeves et al., 2015). Also, it should be noted that these patients had lower inclusion IIEF5 and EHS scores compared to the continent group and that 5 of the 6 incontinent men were initially referred for prostate evaluation due to irritable lower urinary tract symptoms before the RP. This suggests that the incontinent men, have a more advanced neurovascular degeneration altogether which agrees with previous reports showing a difference in spontaneous recovery between continent and incontinent patients (Gandaglia et al., 2012). Finally, there is likely to be a psychological element, since incontinent men may feel less sexually attractive because of the incontinence. We believe the observation that incontinent men have no effect of ADRC therapy for ED is important for future studies and clinical decisions regarding which patient groups should be offered the therapy. ADRC therapy seems to partly alleviate the patient\'s urinary incontinence symptoms as measured by the ICIQ-UI SF scores (Supplemental Fig. S2). While the clinical significance thereof is unclear, these data are promising for treatment of incontinence per se. Our results hold promise for the outcome of other ongoing clinical trials with stem cells for ED therapy, especially one trial in RP patients using allogeneic cultured stem cells derived from bone marrow (NCT01983709), and for tests of mesenchymal stem cells in a wide range of human diseases. For evaluation of the clinical impact, it will be important to characterize the quality, stability and potency of different types and preparations of mesenchymal stem cells. For instance, it is not known if cultured ADRCs or ADRCs from another person, other mesenchymal stem cells or even induced pluripotent stem (iPS) cells would work as well as the freshly isolated stem cells used herein. If cultured non-autologous ADRCs or iPS cells work equally well both from a safety and efficacy point of view, this would have a large impact for the field since cells from stem cell banks could then be used. We investigated ED after RP, which is considered a severe form of ED with nerve injury; however, it is not known if stem cell therapy would work in patients with ED due to diabetes, cardiovascular disease, lower urinary tract diseases or simply age. Our results as well as results from the Korean study in diabetic men (Bahk et al., 2010) suggest that stem cell therapy may be effective for different types of ED.