Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction
45 Years
70 Years
Male
Prostate Cancer, Erectile Dysfunction
Trial Information
Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Absence of serious adverse event (general or local)
Outcome Description:
Side effects envisaged: priapism, local inflammation after cell injection
Outcome Time Frame:
6 months
Safety Issue:
Yes
Authority:
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study ID:
BT06-07
NCT ID:
NCT01089387
Start Date:
April 2010
Completion Date:
June 2012
Related Keywords:
- Prostate Cancer
- Erectile Dysfunction
- radical prostatectomy
- Prostatic Neoplasms
- Erectile Dysfunction
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