Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose- Derived Regenerative Cells in Patients with Erectile Dysfunction.

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Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose- Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial Martha Kirstine Haahr, Charlotte Harken Jensen, Navid Mohamadpour Toyserkani, Ditte Caroline Andersen, Per Damkier, Jens Ahm Sørensen, Lars Lund, Søren Paludan Sheikh EBioMedicine Volume 5, Pages 204-210 (March 2016) DOI: 10.1016/j.ebiom.2016.01.024 Copyright © 2016 The Authors Terms and Conditions

Fig. 1 Study overview. *Some patients were excluded based on several criteria. (IC:Intracavernous; RP:Radical Prostatectomy). EBioMedicine 2016 5, 204-210DOI: (10.1016/j.ebiom.2016.01.024) Copyright © 2016 The Authors Terms and Conditions

Fig. 2 Characterics of the isolated ADRCs. (A) The total yield of nucleated ADRCs per isolation was positively correlated to the input volume of liposuction. (B) ADRC yield per gram fat tissue was independent of donor age. (C) Representative histograms showing expression levels of CD34, CD31, CD73 and CD90 (green) in single-stained ADRCs as analyzed by flow cytometry. The appropriate isotype control is depicted as overlay (purple) in each case. Population percentages are given as mean±SD, n=17. (D) The population of CD235a-CD45-CD31-CD34+ ADRCs was identified in multi-stained samples by flow cytometry using a stepwise gating strategy as indicated by the arrows. The number of cells is expressed as a percentage of the entire single-cell ADRC population (mean±SD, n=3). In each density plot (from one representative patient), the corresponding isotype control is shown as overlay (purple). P-values represent Pearson correlation coefficients in A and B. EBioMedicine 2016 5, 204-210DOI: (10.1016/j.ebiom.2016.01.024) Copyright © 2016 The Authors Terms and Conditions

Fig. 3 Effect of ADRC therapy. (A) IIEF scores for each patient at inclusion, 1, 3 and 6months after a single intracavernous bolus of autologous ADRCs. Patients that regained their ability to have sexual intercourse (green closed circles) had significantly better IIEF scores after 3 and 6months, but not after 1month (Two-Way ANOVA following log transformation). (B, C) Patients were stratified according to their urinary incontinence status. (B) In the group of continent men (n=11), significantly improved IIEF scores were observed after 3 and 6months compared to their inclusion scores (RM one-way ANOVA with Sidak's multiple comparisons test following log transformation). (C) No changes in IIEF scores were observed in the group of incontinent men (n=6) during the study period (RM one-way ANOVA with Sidak's multiple comparisons test, following log transformation). Similarly, the EHS scores were significantly improved after 6months in the continent (D) but not in the incontinent group (E) (Friedman's test with Dunn's multiple comparisons test). (F) Spontaneous reversion of ED post RP in our department was established reviewing 165 medical records. In groups of 135 urine continent men and 30 incontinent men, 40 and 4 men, respectively, showed spontaneous reversion of ED. EBioMedicine 2016 5, 204-210DOI: (10.1016/j.ebiom.2016.01.024) Copyright © 2016 The Authors Terms and Conditions

Supplemental Fig. S1 The time between prostatectomy and ADRC intervention was similar in all groups. The time interval in months between radical prostatectomy and ADRC injection was tested (Mann–Whitney test) in patients grouped according to their (A) urinary continence status, or (B) ability to have sexual intercourse after 6months. In both cases, no significant difference was observed. EBioMedicine 2016 5, 204-210DOI: (10.1016/j.ebiom.2016.01.024) Copyright © 2016 The Authors Terms and Conditions

Supplemental Fig. S2 Urinary continence was improved. Improved urinary continence scores with a reduction in ICIQ-UI SF score 6months post-transplantation was significant for continent men, and a trend was revealed for incontinent men as well (Wilcoxon matched pairs signed rank test). EBioMedicine 2016 5, 204-210DOI: (10.1016/j.ebiom.2016.01.024) Copyright © 2016 The Authors Terms and Conditions