Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-10-31

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.

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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.

Conditions

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Fecal Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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myoblast injection

autologous myoblast

Group Type ACTIVE_COMPARATOR

Myoblast injection

Intervention Type OTHER

Autologous myoblast injection in the anal sphincter

saline solution injection

saline solution injection in anal sphincter

Group Type PLACEBO_COMPARATOR

saline solution injection

Intervention Type PROCEDURE

saline solution injection in anal sphincter

Interventions

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Myoblast injection

Autologous myoblast injection in the anal sphincter

Intervention Type OTHER

saline solution injection

saline solution injection in anal sphincter

Intervention Type PROCEDURE

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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No