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

March 17, 2010
December 29, 2011
April 2010
May 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01089387 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction
Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction

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.

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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Prostate Cancer
  • Erectile Dysfunction
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
Experimental: injection of bone marrow cells
Intervention: Biological: injection of bone marrow mononucleated cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
31
June 2012
May 2012   (final data collection date for primary outcome measure)

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.
Male
45 Years to 70 Years
No
Contact: René Yiou, MD, PhD +33149812553 rene.yiou@hmn.aphp.fr
France
 
NCT01089387
BT06-07, 2008-A01248-47
Yes
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Not Provided
Not Provided
Institut National de la Santé Et de la Recherche Médicale, France
April 2011

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