A 12-Month Follow-up After 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

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OBJECTIVE: To explore safety in adipose-derived regenerative cells (ADRC) therapy, treating ED.

METHODS: Twenty-one patients with ED after radical prostatectomy (RP), with no signs of recovery using conventional therapy, received a single intracavernous injection of autologous ADRC and were followed for 1 year. Six men were incontinent, and 15 were continent at inclusion. The primary (safety of ADRC therapy) and secondary endpoints (sexual function) were evaluated at 1, 3, 6, and 12 months after ADRC injection by registration of adverse events and validated questionnaires using the International Index of Erectile Function-5 (IIEF-5) and Erection Hardness Score (EHS).

RESULTS: No serious adverse events occurred, but 8 reversible minor events related to the liposuction were noted. Eight out of 15 (53%) patients in the continent group reported erectile function sufficient for intercourse at 12 months. Baseline median IIEF-5 scores (6.0; IQR 3) were unchanged 1 month after the treatment, but significantly increased after 6 to 7 (IQR 17). This effect was sustained at 12 months (median 8; IQR 14). We did not see any improvements in erectile function the group of incontinent men or among men with erectile dysfunction prior to radical prostatectomy.

CONCLUSIONS: Intracavernous injection of ADRC is safe in this phase 1 study with a 12 month follow-up.

LanguageEnglish
JournalUrology
ISSN0090-4295
DOIs
StateE-pub ahead of print - 27 Jun 2018