Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30

Summary

Conditions
Fecal Incontinence
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This study is designed to test the safety and feasibility of Autologous Muscle Derived Cells (AMDC) as a treatment for fecal incontinence in men and women. AMDC therapy seeks to allow remodeling of the external anal sphincter in patients with fecal incontinence from either defined structural defects...

This study is designed to test the safety and feasibility of Autologous Muscle Derived Cells (AMDC) as a treatment for fecal incontinence in men and women. AMDC therapy seeks to allow remodeling of the external anal sphincter in patients with fecal incontinence from either defined structural defects to or a generalized weakening of the external anal sphincter.

Tracking Information

NCT #
NCT01600755
Collaborators
Not Provided
Investigators
Principal Investigator: Manoj J Raval, MD St. Paul's Hospital