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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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Erectile Dysfunction
 Biological: injection of bone marrow mononucleated cells
 Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 31
Study Start Date: April 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089387

Contacts
Contact: René Yiou, MD, PhD +33149812553 rene.yiou@hmn.aphp.fr

Locations
France
CHU Henri Mondor-Albert Chenevier-Centre Intercommunal de Créteil Recruiting
Créteil, France, 94101
Contact: Philippe Lecorvoisier, MD, PhD     +33149813785     lecorvoisphilippe.lecorvoisier@hmn.aphp.fr    
Principal Investigator: Hélène Rouard            
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01089387     History of Changes
Other Study ID Numbers: BT06-07, 2008-A01248-47
Study First Received: March 17, 2010
Last Updated: December 29, 2011
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
radical prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013