Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Other: Myoblast injection
* Procedure: saline solution injection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: myoblast injection<br>autologous myoblast | Other: Myoblast injection<br>* Autologous myoblast injection in the anal sphincter<br>|
| Placebo Comparator: saline solution injection<br>saline solution injection in anal sphincter | Procedure: saline solution injection<br>* saline solution injection in anal sphincter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of anal incontinence score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of quality of life score |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal incontinence, Myoblast, Surgery