European, multicentre, single arm (phase I) trial of autologous skeletal muscle derived cell (ASMDC) microcarrier combination for the treatment of faecal incontinence (FI) in women with obstetric anal sphincter injury.

2023-504282-23-00 Protocol AMELIE Human pharmacology (Phase I) - First administration to humans Ended

End 8 May 2026 · Status Ended · 4 EU/EEA countries · 4 sites · Protocol AMELIE

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Ended
Participants planned 10
Countries 4
Sites 4

Faecal incontinence

Key facts

Sponsor
University College London
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Female
Therapeutic area
Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Trial duration
completed 8 May 2026
Decision date (initial)
2025-11-03
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2023-504282-23-00
WHO UTN
U1111-1304-8556

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Faecal incontinence

VersionLevelCodeTermSystem organ class
20.0 LLT 10016296 Fecal incontinence 10017947

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University College London

7 Total trials 2 Recruiting 3 Ended
Academic / Non-commercial
Sponsor organisation
University College London
Address
Gower Street, 5 Gower Place 5 Gower Place
City
London
Postcode
WC1E 6BS
Country
United Kingdom

Scientific contact point

Organisation
University College London
Contact name
Charles H Knowles

Public contact point

Organisation
University College London
Contact name
Trial Manager

Locations

4 EU/EEA countries · 4 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ended 2 1
Denmark Ended 2 1
France Ended 2 1
Spain Ended 2 1
Rest of world
United Kingdom
 — 2 —

Investigational sites

Austria

1 site · Ended
University Hospital Graz
Department of Gynaecology, Auenbruggerplatz 52, 8036, Graz

Denmark

1 site · Ended
Aarhus Universitet
Department of surgery, Palle Juul-Jensens Boulevard 82, 8200, Aarhus N

France

1 site · Ended
Centre Hospitalier Universitaire Rouen
Digestive Physiology, 1 Rue De Germont, Bp 96031, Rouen Cedex

Spain

1 site · Ended
Hospital Universitario Fundacion Jimenez Diaz
Department of surgery, Avenida De Los Reyes Catolicos 2, 28040, Madrid

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-06-13 Austria Acceptable
2025-10-27
 2025-10-28
2 SUBSTANTIAL MODIFICATION SM-1 2025-11-18 Acceptable 2026-01-06