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Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence (MIAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01523522
First received: January 23, 2012
Last updated: June 17, 2014
Last verified: June 2014

January 23, 2012
June 17, 2014
February 2012
December 2014   (final data collection date for primary outcome measure)
Improvement of anal incontinence score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01523522 on ClinicalTrials.gov Archive Site
Improvement of quality of life score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fecal Incontinence
  • Other: Myoblast injection
    Autologous myoblast injection in the anal sphincter
  • Procedure: saline solution injection
    saline solution injection in anal sphincter
  • Active Comparator: myoblast injection
    autologous myoblast
    Intervention: Other: Myoblast injection
  • Placebo Comparator: saline solution injection
    saline solution injection in anal sphincter
    Intervention: Procedure: saline solution injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
February 2015
December 2014   (final data collection date for primary outcome measure)

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)
Both
20 Years to 65 Years
No
Contact: Francis Michot, PhD 33232888573 francis.michot@chu-rouen.fr
France
 
NCT01523522
2009/067/HP
Yes
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Olivier BOYER, PhD Rouen university Hospital
University Hospital, Rouen
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP