Myoblast for Anal Incontinence (MIAS)
This study is currently recruiting participants.
Verified September 2012 by University Hospital, Rouen
Sponsor:
University Hospital, Rouen
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
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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 |
|---|---|---|
|
Anal 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 |
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 |
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
|
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
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: | September 21, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Rouen:
|
Anal incontinence Myoblast Surgery |
ClinicalTrials.gov processed this record on June 18, 2013