Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence (MIAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01523522
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : October 23, 2015
Information provided by (Responsible Party):
University Hospital, Rouen

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 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.

Condition or disease Intervention/treatment Phase
Fecal Incontinence Other: Myoblast injection Procedure: saline solution injection Phase 2 Phase 3

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 realized. after a period of 6 months, patients in the placebo arm receive the injection of myoblasts that have been preserved.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Active Comparator: myoblast injection
autologous myoblast
Other: Myoblast injection
Autologous myoblast injection in the anal sphincter

Placebo Comparator: saline solution injection
saline solution injection in anal sphincter
Procedure: saline solution injection
saline solution injection in anal sphincter

Primary Outcome Measures :
  1. Improvement of anal incontinence score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Improvement of quality of life score [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01523522

Rouen University Hospital
Rouen, France, 76000
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Olivier BOYER, PhD Rouen university Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Rouen Identifier: NCT01523522     History of Changes
Other Study ID Numbers: 2009/067/HP
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: October 2015

Keywords provided by University Hospital, Rouen:
Fecal incontinence

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharmaceutical Solutions