Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence

Fecal Incontinence Clinical Trial

— MIAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523522
• Other study ID #: 2009/067/HP
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 23, 2012
• Last updated: October 22, 2015
• Start date: February 2012
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion criteria

• age between 20 and 65 years

• severe fecal incontinence from at least three months

• Jorge et Wexner score = 10

• incontinence refractory to medical treatment and to reeducation from at least three months

• incontinence due to lesion of the external anal sphincter

• incontinence without significant anal sphincter rupture or rupture = 30% of circumference assessed by endo-anal ultra-sonography

• integrity or not of the internal anal sphincter

• fecal incontinence with normal rectum capacity (maximum tolerable volume = 150 ml assessed by ano-rectal manometry)

• fecal incontinence without associated rectal static disorder on defeco-MRI

• fecal incontinence without bilateral complete neuropathy assessed by electro-physiology

Exclusion criteria

• fecal incontinence with rupture > 30 % of the external anal sphincter

• fecal incontinence with bilateral lesions on the sacral nerves

• Crohn's disease or ulcerative colitis

• unstable type 1 or type 2 diabetes

• myopathy

• peripheral or central neurological diseases

• treatment with laxatives, suppositories or enema

• practice of anal intercourse except if stopped during the study

• treatment with immunosuppressive or cytostatic drugs, CoA HMG reductase inhibitors, morphine derivatives

• treatment of constipation or rectal dyschesia

• pregnancy or breast-feeding,lack of effective contraception during the study (female)

• allergy to antibiotics (cephalexin, metronidazole)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Other:
• Myoblast injection
Autologous myoblast injection in the anal sphincter

Procedure:
• saline solution injection
saline solution injection in anal sphincter

Locations

Country	Name	City	State
France	MICHOT	Rouen
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of anal incontinence score		6 months	Yes
Secondary	Improvement of quality of life score		6 months	Yes