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Tracking Information | |||||
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First Received Date † | May 10, 2007 | ||||
Last Updated Date | September 18, 2007 | ||||
Start Date † | April 2007 | ||||
Current Primary Outcome Measures † |
Clinical tolerance and feasibility of a new therapeutic strategy for stress urinary incontinence based on intra urethral myofiber implantation of autologous myofibers with their satellite cells [ Time Frame: 3 months ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00472069 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Effects of this treatment on urinary continence in order to consider a phase II later on. [ Time Frame: 3 months ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | A New Therapeutic Strategy for Urethral Sphincter Insufficiency | ||||
Official Title † | EVALUATION Of A NEW THERAPEUTIC STRATEGY FOR URETHRAL SPHINCTER INSUFFICIENCY BASED ON THE INTRA-URETHRAL IMPLANTATION OF AUTOLOGOUS MYOFIBERS WITH THEIR SATELLITE CELLS | ||||
Brief Summary | Stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells in the urethra. The aim of this procedure is to generate functional tissue acting like a new sphincter in the urethra |
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Detailed Description | stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells. The principle of this procedure relies on the activation in vivo of the satellite cells present around each myofibers. Satellite cell activation is concomitant with myofiber death that occurs after their implantation. Activated satellite proliferate and fuse to form myotubes replacing the parental myofibers thus leading to the reconstitution of the muscle mass that was initially implanted. Preliminary studies in the pig showed the regenerated muscle tissue in the urethra was innervated by urethral nerves and developed tonic contractions acting like a new sphincter. This procedure does not include a phase of satellite cell amplification ex vivo, as standard methods of satellite cell transfer, and rather relies on the natural myogenic capacities of these cells. Thus, the procedure of cell transfer into the urethra is considerably simplified and can be performed in one step in the operating room.This therapeutic strategy could represent an alternative to the artificial urinary sphincter. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
Condition † |
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Intervention † | Procedure: transplantation of the squeletic muscular cells | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 10 | ||||
Estimated Completion Date | October 2008 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
The myofiber implantation procedure will be proposed after failure of pelvic floor exercises.
Exclusion Criteria:
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Gender | Both | ||||
Ages | 40 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | France | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00472069 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Assistance Publique - Hôpitaux de Paris | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
Verification Date | September 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |