Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction (INSTIN)
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.
|Prostate Cancer Erectile Dysfunction||Biological: injection of bone marrow mononucleated cells||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction|
- Absence of serious adverse event (general or local) [ Time Frame: 6 months ]Side effects envisaged: priapism, local inflammation after cell injection
- Recovery of natural erection, improvement of penile doppler parameters [ Time Frame: 6 month ]Evaluation of erectile recovery using validated quesitonnaires (IIEF15, EHS, UCLA-PCI)
|Study Start Date:||May 2010|
|Study Completion Date:||March 2015|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Experimental: injection of bone marrow cells||
Biological: injection of bone marrow mononucleated cells
Four different concentration of BMMNC will be tested in four groups of 3 patients. In group 5 (n=19): one cell concentration corresponding to the best dose determined by analysis of the previous groups will be tested.
Other Name: cell therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089387
|CHU Henri Mondor-Albert Chenevier-Centre Intercommunal de Créteil|
|Créteil, France, 94101|