AMELIE (Anchored Muscle cELls for IncontinencE)
Research type
Research Study
Full title
AMELIE: European, multicentre, single arm (phase I/IIb) trial of autologous skeletal muscle derived cell (ASMDC) microcarrier combination for the treatment of faecal incontinence (FI) in women with obstetric anal sphincter injury.
IRAS ID
1007874
Contact name
Charles Knowles
Contact email
Sponsor organisation
University College London
ISRCTN Number
ISRCTN10591726
Research summary
Introduction
Faecal Incontinence (FI) is a public health problem with a big impact on people’s quality of life. Women who have given birth form a significant proportion of this patient group, as tears to the perineum during childbirth can lead to faecal incontinence.The AMELIE trial will test safety and efficacy of a cell-based therapy in women with post-obstetric faecal incontinence. To produce this therapy, surgeons will take a muscle biopsy from the patient's chest. This biopsy will be processed to grow muscle cells, which are combined with small porous carrier particles called microcarriers. The combination cell-microcarrier product will be injected to the patient’s external anal sphincter, leading to muscle regeneration.
Trial Design:
AMELIE is an unblinded, single arm trial. This means that all the patients will receive the same treatment and all the patients and their doctors are aware of the treatment. The trial will assess the number of FI episodes, safety and other patient reported outcomes. Data collected during patient’s initial visits will be compared with data collected six months after treatment to assess how effective treatment is.Patients will take part in up to 12 visits. Where time allows, patients may be invited to complete up to two further visits (12 and 18 months after treatment) to allow collection of longer-term data on how safe and effective the treatment is. Participation will last between 10 and 22 months.
Target Sample Size: 33 participants.
Patient Group: Patients must be female, aged ≥ 18 years old, must have chronic faecal incontinence and a history of obstetric anal sphincter injury.
Sites: 7 sites. 2 sites in UK and 5 sites in EU.
Intervention: Autologous skeletal muscle derived cell (ASMDC) PLGA microcarrier combination.
Primary Outcomes:
Safety: number of safety events experienced by patients.
Efficacy: frequency of faecal incontinence episodes recorded in patient’s 28-day bowel diary.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0387
Date of REC Opinion
21 Feb 2025
REC opinion
Further Information Favourable Opinion