Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence

Phase 2

Completed

• Conditions: Fecal Incontinence
• Interventions: Procedure: saline solution injection; Other: Myoblast injection

• Registration Number: NCT01523522
• Lead Sponsor: University Hospital, Rouen

Brief Summary

This project aims to offer autologous muscle-derived progenitor cell injection as an efficient mini-invasive surgical therapy that would be simple for the patient and could be used in a majority of cases, including in young women in the post-partum. This approach may provide efficient tissue repair of the striated anal sphincter which is not permitted by existing therapies. This innovative therapy may ultimately be proposed after failure of the common treatments and before an high-risk invasive surgical intervention. Besides, injection of muscle-derived progenitor cells in animals has shown very encouraging results of the sphincter function assessed ex vivo. Hence, a high benefit may be expected with this approach.

Detailed Description

after verification of information and inclusion criteria. patients were randomized to treatment or placebo arms and receive the injections.

an evaluation of the function and quality of life are realized. after a period of 6 months, patients in the placebo arm receive the injection of myoblasts that have been preserved.

Study Timeline

• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-31
• Study Start: 2012-02
• Study First Posted: 2012-02-01
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-22
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
saline solution injection	saline solution injection	saline solution injection in anal sphincter
myoblast injection	Myoblast injection	autologous myoblast

Primary Outcome Measures

Name	Time	Method
Improvement of anal incontinence score	6 months

Secondary Outcome Measures

Name	Time	Method
Improvement of quality of life score	6 months

Trial Locations

Locations (2)

Rouen University Hospital; 🇫🇷 Rouen, France

MICHOT; 🇫🇷 Rouen, France