Autologous Muscle Derived Cells for Underactive Bladder

Urinary Incontinence Clinical Trial

Official title: Autologous Muscle Derived Cells for Underactive Bladder

Status Completed

Clinical Trial Summary

This is a prospective, open-label, Phase 1, single center study evaluating the safety and efficacy of Autologous Muscle Derived Cells as a treatment for chronic Underactive Bladder.

Clinical Trial Description

Subject that meet inclusion and exclusion criteria will be consented and enrolled in this study. Initial screening includes blood and urine testing, questionnaires, physical examination, specialized bladder function testing and review of medical history. At the next visit a small sample of each subject's own thigh muscle is obtained by needle biopsy. This cell biopsy is sent to a specialized lab for growth and processing. Approximately ten weeks later the frozen cells will be sent back to the treatment site for thawing, diluting and injection under lighted instrumentation into the subject's bladder wall. The subject will be followed for 6 months and at that time may be eligible for a second injection of cells. The study doctor will determine if the second injection may be beneficial to the subject. All subjects will be followed for up to 12 months. The follow-up assessments at 12 months will include questionnaires, urine and blood testing, specialized bladder function testing and visualizing the inside of the bladder with a lighted instrument. ;

Related Conditions & MeSH terms

• Urinary Bladder, Underactive
• Urinary Incontinence
• Urinary Retention

• NCT number: NCT02463448
• Study type: Interventional
• Source: William Beaumont Hospitals
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2016
• Completion date: November 2020