Discussion
The current findings support the safety and potential efficacy of autologous, non-expanded bone marrow concentrate for treatment of ED patients. The current study was limited by the heterogeneity of the patient population as to causes of ED even though the primary recruitment was related to vasculogenic ED. Other studies utilizing autologous bone marrow have been confined to patients post prostatectomy. Despite this, we observed significant improvements in IIEF-5 scores which were superior to the isolated bone marrow cells and/or adipose published clinical trials [31, 32]. The mean IIEF-5 scores observed in PDE5i studies have improved on average of by 8.5 compared to 9 which is what we found the in the clinical registry [33]. The use of autologous bone marrow concentrate is enticing not only because of the known secreted growth factors that are beneficial in ED such as IGF-1 [17,18,19], VEGF [20], and FGF-2 [21], but also because of their anti-inflammatory activities [22], as well as possibility of differentiating into tissue relevant to the penile architecture [23].
Previous clinical studies have supported the safety and potential efficacy of regenerative cell administration into the corpus cavernosum. Yiou et al. studied post-prostatectomy patients administered escalating number of bone marrow mononuclear cells. No serious side effects occurred. At 6 mo versus baseline, significant improvements of intercourse satisfaction and erectile function domains of the International Index of Erectile Function-15 and Erection Hardness Scale (2.6?±?1.1, 1.3?±?0.8, p?=?0.008) were observed in the TOTAL POPULATION [34].
