FI-3 Fidelia
Research type
Research Study
Full title
Skeletal muscle-derived cell implantation for the treatment of fecal incontinence: a phase III, randomized, controlled, double blind, two-armed clinical study
IRAS ID
298744
Contact name
Ekkehart Steinhuber
Contact email
Sponsor organisation
Innovacell AG
Eudract number
2021-001376-42
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 1 months, 0 days
Research summary
Faecal incontinence (FI) is when a person passes gas and/or solid or liquid stools without intending to, or is not able to control when they pass stools. FI can lead to a loss of self-esteem, social isolation and lower quality of life. The muscles in the rectum, anus, and pelvic area help to maintain normal passing of stools (called continence). FI occurs when this group of muscles called the external anal sphincter do not work properly.
Many people with FI can be treated adequately by simple measures such as a change in diet or medications. Surgical treatment is offered to patients with severe FI. However, continence rarely returns to the normal state with these treatments or procedures, and improvement may not last over time.
The investigational treatment being looked at in this study aims to treat the cause of FI and to have a long-term treatment effect.
In this study, a “tissue engineering product” will be applied. Tissue engineering means the use of cells to repair or replace portions or whole tissues or muscles in the body. In this study, the idea is to regain function of the weakened anal sphincter. This is done by growing and reintroducing a patient’s own cells.
To do this, a biopsy will be taken from the chest muscle. A biopsy is a procedure in which a small sample of tissue is taken using a long, thin needle. From the tissue taken, muscle cells will be collected and grown in a special laboratory. The resulting multiplied cells are called autologous skeletal muscle-derived cells, and have the product name ICEF15. These cells will be injected into the weakened sphincter muscle. In this way, the patient’s own cells are used for the study treatment.
In this study, the study treatment will be compared with treatment using a placebo. The comparison with placebo enables us to assess how well the study treatment may work and any side effects of the study treatment.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0191
Date of REC Opinion
24 Sep 2021
REC opinion
Further Information Favourable Opinion