Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction
Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction
Erectile dysfunction is a frequent adverse event after radical prostatectomy for prostate
 cancer.

 It is the consequence of penile vascular damage, mainly arterial insufficiency and venous
 leakage associated with fibrosis of the corpus cavernous. Apoptosis of penile cells,
 including mesenchymal cells, smooth muscle cells and endothelial is believed to play an
 important role in the pathophysiology of post prostatectomy erectile dysfunction.

 Bone marrow mononucleated cells (BMMNC) contain different cell types that may replace the
 damaged penile cells after radical prostatectomy. These are mainly: mesenchymal stem cells,
 endothelial progenitor cells and hematopoietic stem cell. Intracavernous injection of BMMNC
 may therefore find application in the treatment of post prostatectomy erectile dysfunction.

 The aims of this phase I-II study is to test the safety of autologous intracavernous BMMNC
 injection and to evaluate benefit for the patient concerning recovery of natural erection.
 Patients with penile vascular abnormality (echo-doppler) and localized prostate cancer
 (considered as cured by radical prostatectomy) will be included in this study.

 Four different doses of BMMNC will be tested.
We have shown in a rat model of post prostatectomy erectile dysfunction that BMMNC injection
 replace apoptotic cavernous cells and restore erectile function.

 In the pig, the injection of high dose of BMMNC into the corpus cavernosus does not cause
 side effect. Moreover, the BMMNC remains at the injection site.
Inclusion Criteria:

 -  Localized prostate cancer: PSA (Prostate Specific Antigen) prior to radical
 prostatectomy < 10 ng/ml, histopathologic analysis of the prostate showing a prostate
 cancer with Gleason score ≤ 7, negative margin, absence of effraction of the prostatic
 capsule, pT1 or pT2 N0 or NX.

 -  PSA=0 ng/ml 6 months after radical prostatectomy.

 -  Normal erectile function prior to radical prostatectomy.

 -  Penile arterial insufficiency and or venous leakage (doppler) at the time of
 inclusion: PSV <25 cm/sec, PSV >25 cm/sec, EDV>5cm/sec, RI<0,75.

 Exclusion Criteria:

 -  Non localized prostate cancer.