Table 1:
Summary of Studies on SCT/PRP for Disorders of Penile Appearance
| Treatment/ Condition | Study/Year | Cohort | Injection type | Primary endpoint | Results | Serious adverse events |
|---|---|---|---|---|---|---|
| SCT for Erectile Dysfunction | Bahk et al. 2010 [16] | 10 | UC-MSCs | Erectile function | Improved subjective outcomes. 6/7 diabetic treatment patients with morning erections at 2 mo. 2/7 treatment patients able to achieve penetrative sex with PDE5I. No change 3 diabetic controls. | None |
| Al Demour et al. 2018 [17] | 4 | BM-MSCs | Safety and tolerability | 4/4 diabetic patients tolerated procedure well. Significant IIEF-15 improvements in 3/4 pts, all 4 significant EHS. | None | |
| Yiou et al. Phase 1: 2016 Phase II: 2017 [4,18] | 12 | Autologous BM-MNCs 2×10^9 1×10^9 2×10^8 2×10^7 cells |
Tolerance | Significant improvements in IIEF-15 and EHS in post- RP patients. Greater improvements with higher doses. | None | |
| Haahr et al. 2015 [19] | 17 | ADRCs | Adverse events | 11/17 post-RP patients reported improved erectile function. This was not seen in the incontinent group. 8 participants recovered erections capable of intercourse. | None | |
| Levy et al. 2015 [15] | 8 | PM-MSCs | Penile vascular changes | 3/8 pts achieved erections at 3 months. PSV overall showed significant improvements. | None | |
| Protogerou et al 2019 [20] | 8 | Group 1: ADMSCs and platelet lysate Group 2: Platelet lysate |
Efficacy | IIEF-5 scores improved in all pts at 6 mo. No statistically significant difference in scores between groups. Improved penile triplex and morning erections in all patients. | None | |
| Ory et al. 2020 [21] | Data from multiple trials | Allogeneic BM- MSCs vs. Autologous BM-MSCs | IIEF scores | Significantly better erectile function in men using autologous cell sources (p=0.03) or receiving 200 million cells (p=0.014) at 12 month follow up. | None noted | |
| PRP for Erectile Dysfunction | Epifanova et al. 2017, 2020 [23,25] | 75: 30 Group 1 30 Group 2 15 Group 3 |
Study 1: Qualitative/ quantitative analysis of growth factors/platelets from patients with/without ED Study 2: Group1-AA- PRP, Group 2- AA PRP +PDE5I Group 3: Inactivated PRP |
Efficacy of PRP, through PSV and Resistance index (RI) | Study 1: Significant difference in platelet concentration between groups, more growth factors after freezing/thawing. Study 2: Group 1: increase in PSV (P=0.005), RI (P=0.001), IIEF (P=.046), and SEP (P=0.001). Group 2: PSV (P=0.028), RI (P=.129), IIEF (P=0.046) and SEP (P<0.05). Group 3: IIEF-5 and SEP scores (P<0.05) and PSV and RI (P>0.05) |
None |
| Alkhayal and Lourdes 2019 [26] | 267 Full data on 61 |
Intracavernosal PRP following American cellular medicine association protocol | Efficacy, measured by IIEF, GAQ, SEP | Mean IIEF improved pre to post treatment (P<.001), 88.5% (54/61) patients report improved GAQ (erection hardness), 78% achieved successful intercourse (SEP). |
None | |
| Tas et al. 2021 [27] | 31 | Autologous PRP for ED in metabolic syndrome | IIEF-EF | Significant increase in mean IIEF scores compared to baseline in 1st, 3rd, and 6th month after procedure (p<0.001) | 1 patient developed non- symptomatic fibrotic plaque. No other effects | |
| Matz et al. 2018 [5] | 4 | PRFM | Safety | No decline in post vs pre IIEF-5 evaluations. Only 4 minor adverse events. | None | |
| Poulios et al. 2021 [28] | 60 | PRP | MCID in IIEF-EF | 22/29 MCID in PRP group vs 7/28 in placebo (p <0.001) at 1 month. 20/29 MCID in PRP group vs. 7/26 placebo (p <0.001) at 6 months. Statistically significant improvement in Sexual Encounter Profile (SEP) diaries and IIEF-EF scores at each follow up in PRP group compared to placebo. |
None | |
| SCT for PD | Lander et al. 2016 [48] | 11 | SVF injections with shock wave treatment | Safety and subjective outcomes | All patients had subjectively better penile curvature and perceived reduction in plaque size. 7/11 report improved erectile function. Mean erectile hardness grading score increased from 2.7 to 3.5 and mean PDQs scores decreased from 15.0 to 8.7. |
None |
| Levy et al. 2015 [56] | 5 | MSCs from placental matrix | Plaque reduction, PSV | 7/10 treated plaques were completely gone at 3 months. Statistically significant increase in PSV on doppler. | One patient developed priapism and additional plaque | |
| PRP for PD | Marcovici 2019 [59] | 1 | 2 PRP injections 4 weeks apart into maximal penile curvature, and 2x daily penile pump use for 6 weeks | Angle of curvature | After two months angle of curvature significantly reduced. | None noted |
| Virag et al. 2017 [58] | 90 | PRP combined with HA | Penile curvature/ deformation and maximum thickness | Angulation and thickening significantly improved after 4sessions and at last follow-up. Significantly decreased US density of calcified plaques in 6/28 pts after 4 sessions and further improvement with more sessions (p<0.001). |
None | |
| Matz et al. 2018 [5] | 11 | PRFM injections | IIEF-5 scores and penile angle curvature | IIEF-5 scores increased by 4.14from baseline in combined group of ED and PD patients and decreased penile angle curvature reported by 80% patients. | None |
Table Abbreviations:
SCT= Stem Cell Therapy
PRP= Platelet Rich Plasma
ED= Erectile Dysfunction
PD= Peyronie Disease
UC-MSCs= Umbilical Cord derived Mesenchymal Stem Cells
BM- MSCs= Bone Marrow derived Mesenchymal Stem Cells
IIEF=International Index of Erectile Function
IIEF-EF= International Index of Erectile Function- Erectile Function
EHS= Erectile Hardness Score
BM-MNCs= Bone Marrow Mononucleated Cells
ADRCs= Adipose-Derived Regenerative Cells
PM-MSCs= Placental Matrix Mesenchymal Stem Cells
PSV= Peak Systolic Velocity
ADMSCs= Adipose Derived Mesenchymal Stem Cells
AA-PRP= Activated PRP
PDE5I= Phosphodiesterase Type 5 Inhibitors
RI= Resistance Index
SEP= Sexual Encounter Profile
GAQ= Global Assessment Questions
PRFM= Platelet Rich Fibrin-Matrix
MCID= Minimal Clinically Important Difference
SVF= Stromal Vascular Fraction
PDQ= Peyronie Disease Questionnaire
MSCs= Mesenchymal Stem Cells
HA= Hyaluronic Acid
US= Ultrasound