Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-02 @ 12:25 PM
Study NCT ID:
NCT02291432
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2014-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
Sponsor:
Cook MyoSite
Organization:
Study Overview
Official Title:
Muscle Cell Mediated Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery: An Investigation of Cook MyoSite Autologous Muscle Derived Cells
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To study the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.
Detailed Description:
This preliminary, prospective, single-arm clinical study will evaluate the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) that develops following prostate surgery.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: