Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472069
Status:
COMPLETED
Last Update Posted:
2011-05-05
First Post:
2007-05-10
Brief Title:
A New Therapeutic Strategy for Urethral Sphincter Insufficiency
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 roomThis therapeutic strategy could represent an alternative to the artificial urinary sphincter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None