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

NCT01089387 | Completed Phase 1 DMC

• 2 other identifiers: BT06-072008-A01248-47
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction; Prostate Cancer

Keywords

radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• Absence of serious adverse event (general or local)

  Side effects envisaged: priapism, local inflammation after cell injection

  6 months

Secondary Outcomes (1)

• Recovery of natural erection, improvement of penile doppler parameters

  6 month

Study Arms (1)

injection of bone marrow cells

EXPERIMENTAL

Biological: injection of bone marrow mononucleated cells

Interventions

injection of bone marrow mononucleated cells BIOLOGICAL

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.

Also known as: cell therapy

injection of bone marrow cells

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Non localized prostate cancer.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

CHU Henri Mondor-Albert Chenevier-Centre Intercommunal de Créteil

Créteil, 94101, France

Location

Related Publications (3)

• Yiou R, Hamidou L, Birebent B, Bitari D, Le Corvoisier P, Contremoulins I, Rodriguez AM, Augustin D, Roudot-Thoraval F, de la Taille A, Rouard H. Intracavernous Injections of Bone Marrow Mononucleated Cells for Postradical Prostatectomy Erectile Dysfunction: Final Results of the INSTIN Clinical Trial. Eur Urol Focus. 2017 Dec;3(6):643-645. doi: 10.1016/j.euf.2017.06.009. Epub 2017 Jun 24.

  PMID: 28753830 RESULT

• Yiou R, Hamidou L, Birebent B, Bitari D, Lecorvoisier P, Contremoulins I, Khodari M, Rodriguez AM, Augustin D, Roudot-Thoraval F, de la Taille A, Rouard H. Safety of Intracavernous Bone Marrow-Mononuclear Cells for Postradical Prostatectomy Erectile Dysfunction: An Open Dose-Escalation Pilot Study. Eur Urol. 2016 Jun;69(6):988-91. doi: 10.1016/j.eururo.2015.09.026. Epub 2015 Oct 4.

  PMID: 26439886 RESULT

• Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015 May;12(5):1105-6. doi: 10.1111/jsm.12871. No abstract available.

  PMID: 25974235 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: March 1, 2015
• Last Updated: December 4, 2025

Record last verified: 2011-04

Locations

FR (1)