NCT01600755

Autologous Cell Therapy for Treatment of Fecal Incontinence

A Prospective Nonrandomized Study of Autologous Muscle Derived Cell (AMDC) Transplantation for Treatment of Fecal Incontinence

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Cook MyoSite · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment of patients with fecal incontinence.

Detailed description

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

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	Iltamiocel	Single intrasphincteric injection of iltamiocel at a dose of 250 x 10\^6 cells

Timeline

• Start date: 2013-03-28
• Primary completion: 2021-10-27
• Completion: 2021-10-27
• First posted: 2012-05-17
• Last updated: 2024-02-16
• Results posted: 2024-02-16

Locations

2 sites across 2 countries: Canada, United Kingdom