Safety of Intracavernous Bone Marrow-Mononuclear Cells for Postradical Prostatectomy Erectile Dysfunction: An Open Dose-Escalation Pilot Study

Evidence from animal models replicating postradical prostatectomy erectile dysfunction (pRP-ED) suggests intracavernous injection of bone marrow-mononuclear cells (BM-MNCs) as a promising treatment approach for pRP-ED.

We conducted a phase 1/2 pilot clinical trial of intracavernous autologous BM-MNC injection to treat pRP-ED (NCT01089387). Twelve patients with localized prostate cancer and vasculogenic pRP-ED refractory to maximal medical treatment were divided into four equal groups treated with escalating BM-MNC doses (2×10(7), 2×10(8), 1×10(9), 2×10(9)). Tolerance was the primary endpoint. Secondary endpoints were the effects on erectile function and penile vascularization at 6 mo, as assessed using the International Index of Erectile Function-15 and Erection Hardness Scale questionnaires, and color duplex Doppler ultrasound. We measured the peak systolic velocity in cavernous arteries and assessed endothelial function using the penile nitric oxide release test. No serious side effects occurred. At 6 mo versus 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 International Index of Erectile Function-15 and Erection Hardness Scale (2. 6±1. 1, 1. 3±0. 8, p=0. 008) were observed in the total population. Spontaneous erections showed significantly greater improvement with the higher doses. Clinical benefits were associated with improvement of peak systolic velocity and of % penile nitric oxide release test and sustained after 1 yr. Our results need to be confirmed by phase 2 clinical trials.

We report a phase 1/2 pilot clinical trial investigating cell therapy with injection of bone marrow mononucleated cells to treat postradical prostatectomy erectile dysfunction. No serious side effects occurred. Improvements of erectile function and penile vascularization were noted. Further studies are required to confirm these preliminary results.

European urology. 2015 Oct 01 [Epub ahead of print]

René Yiou, Leila Hamidou, Brigitte Birebent, Dalila Bitari, Philippe Lecorvoisier, Isabelle Contremoulins, Muhieddine Khodari, Anne-Marie Rodriguez, Déborah Augustin, Françoise Roudot-Thoraval, Alexandre de la Taille, Hélène Rouard

APHP, Urology Department, Henri Mondor Teaching Hospital, Créteil, France. APHP, Department of Physiology, Henri Mondor Teaching Hospital, Créteil, France. , Etablissement Français du Sang, Unité d'Ingénierie et de thérapie cellulaire, Créteil, France. , APHP, CIC-P006, and CIC-BT 504, Henri Mondor Teaching Hospital, Créteil, France. , APHP, CIC-P006, and CIC-BT 504, Henri Mondor Teaching Hospital, Créteil, France. , APHP, Anesthesiology Department, Henri Mondor Teaching Hospital, Créteil, France. , APHP, Urology Department, Henri Mondor Teaching Hospital, Créteil, France. , INSERM, U955, UPEC, Créteil, France. , APHP, Urology Department, Henri Mondor Teaching Hospital, Créteil, France. , APHP, Department of Public Health of Statistics, Henri Mondor Teaching Hospital, Créteil, France. , APHP, Urology Department, Henri Mondor Teaching Hospital, Créteil, France. , Etablissement Français du Sang, Unité d'Ingénierie et de thérapie cellulaire, Créteil, France.

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