STEFFI
Research type
Research Study
Full title
Skeletal muscle-derived cell implantation for the treatment of Faecal Incontinence: a multicentre, randomised, double-blind, placebo-controlled, parallel-group, dose-finding clinical study.
IRAS ID
129032
Contact name
Anton Emmanuel
Contact email
Sponsor organisation
Innovacell Biotechnologie AG
Eudract number
2010-021463-32
ISRCTN Number
n/a
Research summary
Faecal incontinence (FI), the involuntary loss of flatus (’wind’) and/or solid or liquid stool or the inability to control the passage of faeces through the anus, is common and can be a devastating social disability. Currently, treatments for FI are limited.
This study is to investigate a therapy which uses cells taken from the patient; multiplied in a laboratory and then injected into the anal sphincter muscles to replace, repair or help the damaged tissue. The aim of the study is to find the optimal number of cells to improve the function of the external anal sphincter.
Patients will be allocated by chance either treatment with an injection of their own cells at a high cell count, at a low cell count or a ‘dummy’ injection (placebo). Patients allocated to placebo or the low cell count will have the opportunity to have the optimal number of cells implanted at the end of the study.
The study will be carried out throughout Europe with one participating site in the UK.
Male and female patients aged 18 and over who have suffered with FI for over 6 months and have fairly severe symptoms will be eligible to participate. The patient will also be checked for a number of exclusion criteria at screening.
Patients will attend the clinic for 9 visits over 22 months for Screening, Biopsy, Implantation and six Follow-up visits. The Biopsy will be taken from muscle in the upper arm under a local anaesthetic. Implantation (injection) will be carried out under medication for pain/sedation or under general anaesthetic if the patient prefers.
Assessments will include rectoscopy, ultrasound and sonography to ‘see’ the affected area and manometry to check how well the sphincter is working. The patient will also be asked to complete a diary and to complete a number of health questionnaires throughout.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0294
Date of REC Opinion
4 Nov 2013
REC opinion
Further Information Favourable Opinion