Myoblast for Anal Incontinence (MIAS)

This study is currently recruiting participants.

Verified September 2012 by University Hospital, Rouen

Sponsor:

Information provided by (Responsible Party):

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT01523522

First received: January 23, 2012

Last updated: September 21, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 23, 2012

Last Updated Date

September 21, 2012

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01523522 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Myoblast for Anal Incontinence

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Anal Incontinence

Intervention ^ICMJE

Other: Myoblast injection
Autologous myoblast injection in the anal sphincter
Procedure: saline solution injection
saline solution injection in anal sphincter

Study Arm (s)

Active Comparator: myoblast injection
Intervention: Other: Myoblast injection
Placebo Comparator: saline solution injection
saline solution injection in anal sphincter

Intervention: Procedure: saline solution injection

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2015

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

20 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Francis Michot, PhD

33232888573

francis.michot@chu-rouen.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01523522

Other Study ID Numbers ^ICMJE

2009/067/HP

Has Data Monitoring Committee

Yes

Responsible Party

University Hospital, Rouen

Study Sponsor ^ICMJE

University Hospital, Rouen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

University Hospital, Rouen

Verification Date

September 2012

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

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