Status:
COMPLETED
Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence
Lead Sponsor:
University Hospital, Rouen
Conditions:
Fecal Incontinence
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
PHASE3
Brief 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 ca...
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 reali...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01523522
Start Date
February 1 2012
End Date
October 1 2015
Last Update
October 23 2015
Active Locations (2)
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1
Rouen University Hospital
Rouen, France, 76000
2
MICHOT
Rouen, France, 76031