Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction

Phase 1

Completed

• Conditions: Erectile Dysfunction; Prostate Cancer
• Interventions: Biological: injection of bone marrow mononucleated cells

• Registration Number: NCT01089387
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-17
• Study First Posted: 2010-03-18
• Study Start: 2010-05
• Status Verified: 2011-04
• Primary Completion: 2012-05
• Study Completion: 2015-03
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
injection of bone marrow cells	injection of bone marrow mononucleated cells	-

Primary Outcome Measures

Name	Time	Method
Absence of serious adverse event (general or local)	6 months	Side effects envisaged: priapism, local inflammation after cell injection

Secondary Outcome Measures

Name	Time	Method
Recovery of natural erection, improvement of penile doppler parameters	6 month	Evaluation of erectile recovery using validated quesitonnaires (IIEF15, EHS, UCLA-PCI)

Trial Locations

Locations (1)

CHU Henri Mondor-Albert Chenevier-Centre Intercommunal de Créteil; 🇫🇷 Créteil, France