search
Back to results

Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence (MIAS)

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Myoblast injection
saline solution injection
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal incontinence, Myoblast, Surgery

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Rouen University Hospital
  • MICHOT

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

myoblast injection

saline solution injection

Arm Description

autologous myoblast

saline solution injection in anal sphincter

Outcomes

Primary Outcome Measures

Improvement of anal incontinence score

Secondary Outcome Measures

Improvement of quality of life score

Full Information

First Posted
January 23, 2012
Last Updated
October 22, 2015
Sponsor
University Hospital, Rouen
search

1. Study Identification

Unique Protocol Identification Number
NCT01523522
Brief Title
Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence
Acronym
MIAS
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Fecal incontinence, Myoblast, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
myoblast injection
Arm Type
Active Comparator
Arm Description
autologous myoblast
Arm Title
saline solution injection
Arm Type
Placebo Comparator
Arm Description
saline solution injection in anal sphincter
Intervention Type
Other
Intervention Name(s)
Myoblast injection
Intervention Description
Autologous myoblast injection in the anal sphincter
Intervention Type
Procedure
Intervention Name(s)
saline solution injection
Intervention Description
saline solution injection in anal sphincter
Primary Outcome Measure Information:
Title
Improvement of anal incontinence score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement of quality of life score
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier BOYER, PhD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
MICHOT
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25565635
Citation
Bisson A, Le Corre S, Joly-Helas G, Chambon P, Demoulins L, Jean L, Adriouch S, Drouot L, Giverne C, Roussel F, Jacquot S, Doucet C, Michot F, Lamacz M, Frebourg T, Flaman JM, Boyer O. Chromosomal instability but lack of transformation in human myoblast preparations. Cell Transplant. 2014;23(12):1475-87. doi: 10.3727/096368913X670192.
Results Reference
derived

Learn more about this trial

Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence

We'll reach out to this number within 24 hrs