Table 3. Summary of emerging therapy for ED: stem cell therapy.
| Compound | Type of study | Route of administration FU duration | Population studied | Main findings | Date (year) | Author |
|---|---|---|---|---|---|---|
| Umbilical cord-derived SCs | Phase I single-blind study | Single ICI 9 mo FU | Type 2 DM with ED (n=7) | 6/7 patients experienced morning erection by the third mo and maintained for more than 6 mo. | 2010 | Bahk et al [79] |
| 2/7 patients achieved penetration with the addition of PDE5-I. | ||||||
| Adipose-derived regenerative cells | Phase I open-label, single arm study | Single ICI 6 mo FU | Post-RP ED (n=17) | 8 of 17 men recovered their erectile function and were able to accomplish sexual intercourse. | 2016 | Haahr et al [80] |
| For continent men, 8 of 11 men recovered erectile function. Median IIEF-5 score increased from 7 to 17 for 6 mo after ICI. | ||||||
| No serious AE were reported. Minor events related to the liposuction and SC injection at the 1-mo. | ||||||
| Adipose-derived regenerative cells | Phase I open-label, single arm study | Single ICI 12 mo FU | Post-RP ED (n=21) | 8 out of 15 patients (53%) in the continent group reported erectile function sufficient for intercourse at 12 mo. | 2018 | Haahr et al [81] |
| Median IIEF-5 score in continent group increased from 6 to 11 after 6 mo. | ||||||
| No serious adverse events occurred. | ||||||
| Placental-derived stem cells | Phase I/II | Single ICI 6 mo FU | Non-responders to PDE5-I (n=8) | No serious adverse effects were noticed. | 2016 | Levy et al [82] |
| At 6 mo, PSV ranged from 25.5 to 73.9 cm/s. The increase in PSV was statistically significant (p<0.05). | ||||||
| Changes in measured EDV, stretched penile length, width, and IIEF score were not statistically significant. | ||||||
| Bone marrow-mononuclear cells | Phase I/II | Single ICI 12 mo FU | Vasculogenic post-RP ED (n=12) | No serious side effects occurred. | 2016 | Yiou et al [83] |
| At 6 mo vs. baseline, significant improvements of intercourse satisfaction (6.8±3.6, 3.9±2.5; p=0.044) and erectile function (17.4±8.9, 7.3±4.5; p=0.006) domains of the IIEF-15 and (2.6±1.1, 1.3±0.8; p=0.008) were observed. | ||||||
| Bone marrow-mononuclear cells | Single ICI mean 62.1 mo FU | Post-RP ED (n=18) | No serious side effects occurred. | 2017 | Yiou et al [84] | |
| After 6 mo, significant improvements vs. baseline were noted in IIEF-15 intercourse satisfaction (7.8±3.1 vs. 2.2±3.4; p=0.033) and erectile function (18±8.3 vs. 3.7±4.1; p=0.035) domains. | ||||||
| After a mean follow-up of 62.1 mo, erectile function scores were slightly lower compared with the 1-y time point. | ||||||
| Bone marrow derived mesenchymal stem cells | Phase I open label clinical trial | Two ICI Safety: 24 mo FU Efficacy: 12 mo FU |
Type 2 DM with ED (n=4) | No patients reported significant adverse effects. | 2018 | Al Demour et al [85] |
| There was significant improvement of IIEF-15 and EHS; IIEF-15 (p=0.04), erectile function (p=0.03), sexual desire (p=0.04), intercourse satisfaction (p=0.04), and overall satisfaction (p=0.04). |
ED: erectile dysfunction, FU: follow-up, SC: stem cell, ICI: intracavernosal injection, DM: diabetes mellitus, PDE5-I: phosphodiesterase type 5 inhibitor, Post-RP: post prostatectomy, IIEF: international index of erectile function, AE: adverse events, PSV: peak systolic velocity, EDV: end diastolic velocity, EHS: erection hardness scale.