NCT02291432

Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery

Muscle Cell Mediated Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery: An Investigation of Cook MyoSite Autologous Muscle Derived Cells

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Cook MyoSite · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence
• Stress
• Urination Disorders
• Urologic Diseases
• Lower Urinary Tract Symptoms
• Urological Manifestations

Interventions

Type	Name	Description
BIOLOGICAL	autologous muscle-derived cells (AMDC)	Cell treatment

Timeline

• Start date: 2015-02-19
• Primary completion: 2019-06-28
• Completion: 2019-06-28
• First posted: 2014-11-14
• Last updated: 2021-11-01
• Results posted: 2021-10-26

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study