A Randomized Double-blind, Placebo-controlled Trial of Adipose-derived Regenerative Cells Injected into Corpora Cavernosum Following Radical Prostatectomy

BACKGROUND AND OBJECTIVE: Erectile dysfunction (ED) following radical prostatectomy (RP) has a negative impact on quality of life. Herein, the aim was to assess the effectiveness of autologous adipose-derived regenerative cells (ADRCs) for treating ED after RP. METHODS: This was a randomized, double-blinded, placebo-controlled study. A total of 70 men with ED were enrolled at Odense University Hospital, Denmark. Patients received one intracavernous bolus of ADRCs (n = 35) or placebo (n = 35). The primary endpoint was a change in the International Index of Erectile Function 5 (IIEF-5) at 12 mo after intervention versus baseline. The secondary endpoints were changes in Erectile Hardness Scale (EHS) and RigiScan values at 6 mo versus baseline. KEY FINDINGS AND LIMITATIONS: There was no significant difference between the two groups in IIEF-5 (p > 0.99) and EHS (p = 0.85) scores. RigiScan values showed no overall effect of ADRCs versus placebo (tumescence activity units at the tip of the penis p = 0.19 and the base of the penis p = 0.60, and rigidity activity units at the tip of the penis p = 0.97 and the base of the penis p = 1). No severe adverse events were observed, and none had prostate-specific antigen relapse. Study limitations include the use of online surveys for patient registration of IIEF-5 and EHS scores. CONCLUSIONS AND CLINICAL IMPLICATIONS: Intracavernous injections of ADRCs appear safe, but had no measurable effect on ED after RP and thus cannot be recommended in its current form.