NCT01523522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2012

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

3.7 years

First QC Date

January 23, 2012

Last Update Submit

October 22, 2015

Conditions

Fecal Incontinence

Keywords

Fecal incontinenceMyoblastSurgery

Outcome Measures

Primary Outcomes (1)

  • Improvement of anal incontinence score

    6 months

Secondary Outcomes (1)

  • Improvement of quality of life score

    6 months

Study Arms (2)

myoblast injection

ACTIVE COMPARATOR

autologous myoblast

Other: Myoblast injection

saline solution injection

PLACEBO COMPARATOR

saline solution injection in anal sphincter

Procedure: saline solution injection

Interventions

Myoblast injectionOTHER

Autologous myoblast injection in the anal sphincter

myoblast injection
saline solution injectionPROCEDURE

saline solution injection in anal sphincter

saline solution injection

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rouen University Hospital

Rouen, 76000, France

Location

MICHOT

Rouen, 76031, France

Location

Related Publications (1)

  • 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.

    PMID: 25565635DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Olivier BOYER, PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

February 1, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 23, 2015

Record last verified: 2015-10

Locations

FR(2)