Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence (MIAS)

University Hospital, Rouen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Fecal Incontinence

Treatments: Procedure: saline solution injection; Other: Myoblast injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01523522

2009/067/HP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

myoblast injection

Active Comparator group

Description:

autologous myoblast

Treatment:

Other: Myoblast injection

saline solution injection

Placebo Comparator group

Description:

saline solution injection in anal sphincter

Treatment:

Procedure: saline solution injection