Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence (MIAS)

This study is currently recruiting participants.
Verified October 2013 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01523522
First received: January 23, 2012
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Fecal Incontinence
Other: Myoblast injection
Procedure: saline solution injection
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Improvement of anal incontinence score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement of quality of life score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523522

Contacts
Contact: Francis Michot, PhD 33232888573 francis.michot@chu-rouen.fr

Locations
France
Rouen University Hospital Active, not recruiting
Rouen, France, 76000
MICHOT Recruiting
Rouen, France, 76031
Contact: Francis MICHOT, PR       francis.michot@chu-rouen.fr   
Contact: Olivier BOYER, PR       olivier.boyer@chu-rouen.fr   
Principal Investigator: Francis MICHOT, PR         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Olivier BOYER, PhD Rouen university Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01523522     History of Changes
Other Study ID Numbers: 2009/067/HP
Study First Received: January 23, 2012
Last Updated: October 15, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Rouen:
Fecal incontinence
Myoblast
Surgery

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

ClinicalTrials.gov processed this record on April 17, 2014