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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Institut National de la Santé Et de la Recherche Médicale, France

ClinicalTrials.gov Identifier:

NCT01089387

First received: March 17, 2010

Last updated: December 29, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 17, 2010

Last Updated Date

December 29, 2011

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Absence of serious adverse event (general or local) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Side effects envisaged: priapism, local inflammation after cell injection

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01089387 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Recovery of natural erection, improvement of penile doppler parameters [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Evaluation of erectile recovery using validated quesitonnaires (IIEF15, EHS, UCLA-PCI)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Prostate Cancer
Erectile Dysfunction

Intervention ^ICMJE

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

Study Arm (s)

Experimental: injection of bone marrow cells

Intervention: Biological: injection of bone marrow mononucleated cells

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2012

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

45 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: René Yiou, MD, PhD

+33149812553

rene.yiou@hmn.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01089387

Other Study ID Numbers ^ICMJE

BT06-07, 2008-A01248-47

Has Data Monitoring Committee

Yes

Responsible Party

Institut National de la Santé Et de la Recherche Médicale, France

Study Sponsor ^ICMJE

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Institut National de la Santé Et de la Recherche Médicale, France

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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