NCT01953315

Muscle Progenitor Cell Therapy for Urinary Incontinence

A Phase 1 Pilot Safety and Feasibility Study of Muscle Progenitor Cell (MPC) Therapy for Urinary Incontinence

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety of muscle progenitor cells (MPCs) for the treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).

Detailed description

Eligible subjects with a diagnosis of urinary incontinence who give consent to take part will undergo a biopsy of the muscle from the inner thigh under anesthesia. The muscle sample will be cultured and expanded for approximately 6 weeks. The product, composed of autologous, ex vivo-expanded muscle progenitor cells (MPCs) in suspension, will be delivered via targeted injection into the bladder neck sphincter region using either an endoscopic needle via a cystoscope or periurethral injection under ultrasound guidance. All subjects will be followed at 1 week, 6 weeks, 3 months, 6 months and 12 months post-injection.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Muscle Progenitor Cells	Autologous MPCs, administered via a single, direct injection into the bladder neck sphincter region

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2013-09-30
• Last updated: 2024-03-01

Locations

2 sites across 1 country: United States