Autologous myoblasts for treatment of anal incontinence due to anal sphincter defects - Fecal incontinence 1

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003759-11-AT

Enrollment

Registered

2007-02-23

Start date

2007-03-09

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal (anal) inconinence caused by ruptures/ traumas of the external anal sphincter

Interventions

Product Name: Autologous myoblasts Product Code: AM Pharmaceutical Form: Living tissue equivalent

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Neurological reason for incontinence Chemotherapy, Radiotherapy Immunosuppressive Therapy Severe allergy to gentamycin or bovine proteins Pregnancy Contraindication to surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: Amelioration of the incontinence score of treated patients;Secondary Objective: Safety and feasibilty of autologous myoblast transplantation to the external anal sphincter Improvement of quality of life (Quality of life score) Sonographic evaluation of sphincter and anal closure aparatus morphology 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.	—

Measure

Time frame

Main Objective: Amelioration of the incontinence score of treated patients;Secondary Objective: Safety and feasibilty of autologous myoblast transplantation to the external anal sphincter Improvement of quality of life (Quality of life score) Sonographic evaluation of sphincter and anal closure aparatus morphology 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.

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026