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

Table 4 Color Duplex Doppler Utrasound of the penis (CDDU) before and after BM-MSC injections

	Baseline (before BM-MSC injection) (n = 8)	3-month (after second BM-MSC injection) (n = 8)	P-Value
Basal PSV Mean±SD	12.25±2.5	16.5±3	0.0039
Basal EDV Mean±SD	6.6±2.4	6.2±2.7	0.1250
Basal RI Mean±SD	0.95±0.09	0.92±0.1	0.1250
20 min PSV Mean±SD	25.3±3.7	31.4±6.3	0.0055
20 min EDV Mean±SD	6.2±2.5	5.9± 2.6	0.3750
20 min RI Mean±SD	0.8±0.3	1.2±0.9	0.8146

Changes in meqan color duplex Doppler ultrasound parameters after the intracavernous injection of BM-MSC. We assessed penile vascularization by measuring peak systolic velocity (PSV), end-diastolic velocity (EDV), and the resistive index (RI) in both cavernosal arteries before (basal PSV, basal EDV, basal RI) and 20 min after an intracavernous (IC) injection of 20 μg of alprostadil (20-min PSV; 20 min-EDV; 20-min RI). Significant differences versus baseline are in bold type. Values are presented as mean ± standard deviation. The statistical analysis is performed via Wilcoxon signed rank test
PSV peak systolic velocity, EDV end-diastolic velocity, RI resistive index, BM-MSCs bone marrow mesenchymal stem cells, IC intracavernous, SD standard deviation, CDDU Penile Color Duplex Doppler Ultrasound, basal: before IC injection of 20 µg of alprostadil injection, 20 min : 20 min after IC injection of 20 µg of alprostadil injection

ISSN: 2051-4190