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

Prostate Cancer Clinical Trial

— INSTIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089387
• Other study ID #: BT06-07
• Secondary ID: 2008-A01248-47
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 17, 2010
• Last updated: November 17, 2016
• Start date: May 2010
• Est. completion date: March 2015

Study information

• Verified date: April 2011
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2015
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 70 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer

Intervention

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.

Locations

Country	Name	City	State
France	CHU Henri Mondor-Albert Chenevier-Centre Intercommunal de Créteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of serious adverse event (general or local)	Side effects envisaged: priapism, local inflammation after cell injection	6 months	Yes
Secondary	Recovery of natural erection, improvement of penile doppler parameters	Evaluation of erectile recovery using validated quesitonnaires (IIEF15, EHS, UCLA-PCI)	6 month	No