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

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ClinicalTrials.gov Identifier: NCT01089387
Recruitment Status : Completed
First Posted : March 18, 2010
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Tracking Information
First Submitted Date  ICMJE March 17, 2010
First Posted Date  ICMJE March 18, 2010
Last Update Posted Date November 18, 2016
Study Start Date  ICMJE May 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2010)
Absence of serious adverse event (general or local) [ Time Frame: 6 months ]
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
 (submitted: March 17, 2010)
Recovery of natural erection, improvement of penile doppler parameters [ Time Frame: 6 month ]
Evaluation of erectile recovery using validated quesitonnaires (IIEF15, EHS, UCLA-PCI)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE Experimental: injection of bone marrow cells
Intervention: Biological: injection of bone marrow mononucleated cells
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2016)
18
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2010)
31
Actual Study Completion Date  ICMJE March 2015
Actual 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01089387
Other Study ID Numbers  ICMJE BT06-07
2008-A01248-47 ( Other Identifier: Afssaps )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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