Autologous myoblasts for treatment of anal incontinence due to anal sphincter defects - Fecal incontinence 1
- Conditions
- Fecal (anal) inconinence caused by ruptures/ traumas of the external anal sphincter
- Registration Number
- EUCTR2005-003759-11-AT
- Lead Sponsor
- BKH Schwaz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 10
Inclusion Criteria
Anal incontinence caused by external sphincter defects
Age 20-80
Signed informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Neurological reason for incontinence
Chemotherapy, Radiotherapy
Immunosuppressive Therapy
Severe allergy to gentamycin or bovine proteins
Pregnancy
Contraindication to surgery
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Amelioration of the incontinence score of treated patients;Secondary Objective: Safety and feasibilty of autologous myoblast transplantation to the external anal sphincter<br>Improvement of quality of life (Quality of life score)<br>Sonographic evaluation of sphincter and anal closure aparatus morphology<br>Ano- rectal manometry;Primary end point(s): Last visit in the hospital for asessment of the continence staus of the patient 12 months after the implantation of the cells.
- Secondary Outcome Measures
Name Time Method