NCT01523522

Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence

Etude de l'efficacité et de la sécurité d'Injections Intra-sphinctériennes de Myoblastes Autologues Chez Des Patients Atteints d'Incontinence Anale sévère Par Insuffisance sphinctérienne

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
OTHER	Myoblast injection	Autologous myoblast injection in the anal sphincter
PROCEDURE	saline solution injection	saline solution injection in anal sphincter

Timeline

• Start date: 2012-02-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-02-01
• Last updated: 2015-10-23

Locations

2 sites across 1 country: France