Table 2.

Clinical trials with stem cell therapy and stromal vascular fraction

Intervention	Authors	Year	Patients	Study design	Stem cell type	Findings:
SCT	Bahk et al	2010	n = 7	non-randomized, single-blind study	Umbilical Cord Blood-derived	Diabetic ED patients treated single injection of cavernosal stem cells. 6/7 patients regained morning erections by 3 months, 2/7 regained rigidity enough for penetrance with aid of PDE5i.
	Levy et al	2015	n = 8	non-randomized, open-label	Placnetal matrix-derived	Heterogenous ED patients treated with single cavernosal injection of stem cells. 3/8 patients achieved erections at 3 months, and PSV increased from 50.7 cm/s to 73.9 cm/s at 6 months.
	Yiou et al	2016	n = 12	non-randomized, pilot	Bone marrow mesenchymal	Post-prostatectomy patients in 4 groups, each group treated with a different dosage of cavernosal injected stem cells. No serious side effects. Significant improvement in IIEF-15 and EHS obersved at 6 months. Higher dosage of stem cells showed signficant improvement in spontaneous erections
	Yiou et al	2017	n = 6	non-randomized, pilot	Bone marrow mesenchymal	Longer update on prior study and included 6 additional post-prostatectomy patients who saw similar findings in improvements of IIEF-15 and EHS. No prostate cancer recurrence from first study after following for 62.1 ± 11.7 months
	Al Demour et al	2018	n=4	non-randomized, open-label	Bone marrow mesenchymal	Diabetic ED patients treated with 2 consecutive cavernosal injections. No reported adverse effects. Significant improvement in IIEF-15 and EHS.
	Schweizer et al	2019	n=7	non-randomized, pilot	Bone marrow mesenchymal	Prostatectomy patients treated with single IV infuction of stem cells in 2 groups based on dosing several days prior to prostatectomy. No dose limiting toxicity was observed. No stem cells were detected in all subjects and no stem cells were noted in prostate specimen. At 2 years post prostatecotmy, there was no cancer recurrrence. Function studies showed significnat improvement of sexual function over the course of the study,
SVF	Haahr et al	2016	n=17	non-randomized, open label	Autologous adipose-derived	Post-prostatectomy patients were treated with single cavernosal injection. No major adverse events, minor events relatd to liposuction and ecchymosis from injection. 8/17 patients recovered erectile function to perform sexual intercourse. In post-hoc stratification, of the continent prostatectomy men 8/11 recovered erectile function, no incontinent man regained erectile function
	Haahr et al	2018	n = 21	non-randomized, open-label	Autologous adipose-derived	Post-prostatectomy patients were treated with single cavernosal injection. No major adverse events, 8 minor events related to liposuction. 8/15 of patients in continent group report erectile function enough for penetrance at 12 months. IIEF-5 unchanged at 1 month post treatment, but significantly increased at 6-7 months post tretment and sustained at 12 months.
	Khera et al	2019	n = 30	randomized, with delayed cross over	Autologous adipose-derived	Heterogenous ED patients were treated with SVF injections. Importantly, patients abstained from erectogenic medications for 6 months following injections. Minor adverse events noted include pain and swelling at site of injection or liposuction. In treated patinets IIEF-EF scores improved at least 2-4 points from baseline starting at 3 months sustained through 9 months. Control experience no benefits at 6 months of treatment.