STEFFI

• Research type

  Research Study

• Full title

  Skeletal muscle-derived cell implantation for the treatment of fecal incontinence: a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding clinical study

• IRAS ID

  70111

• Sponsor organisation

  Innovacell Biotechnologie AG

• Eudract number

  2010-021463-32

• ISRCTN Number

  not known

• Research summary

  Anal incontinence, a condition for which currently no effective long-term therapy exists, severely impairs social and personal life style of those affected. Patients that will be enrolled in this study suffer from anal incontinence diagnosed with anal sphincter weakness. By means of a novel ultra-sound guided implantation technique applying skeletal muscle derived cells (SMDCs) trans-muscular into the damaged anal sphincter, anal continence should be improved. SMDCs will be extracted in a minimal invasive biopsy, cultivated and enlarged in numbers to be re-implanted. This technique was already successfully applied on a limited number of patients (see Frudinger et al 2010). Consequently, an improvement of life quality and a reduction of incontinence episodes was demonstrated. Moreover, trans-urethral usage of SMDC??s have successfully been used in the recent past to enhance stress urinary incontinence. The aim of this study is to find the optimal cell count for functional regeneration of the anal sphincter, that in turn improves life quality. The present study should demonstrate superiority of the cell therapy to a placebo treatment.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  11/LO/0550

• Date of REC Opinion

  20 Sep 2011

• REC opinion

  Further Information Favourable Opinion