Cook MyoSite 15-06 CELLEBRATE: AMDC-USR vs Placebo in Females with SUI
Research type
Research Study
Full title
CELLEBRATE: An Adaptive, Two-Stage, Double-Blind, Stratified, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR with Placebo in Female Subjects with Stress Urinary Incontinence
IRAS ID
231584
Contact name
Anupreet Dua
Contact email
Sponsor organisation
Cook MyoSite
Eudract number
2017-000956-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This is a phase III, two-stage, double-blind, stratified, randomised, placebo-controlled, multicentre,adaptive design study to evaluate the efficacy and safety of a new treatment called Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared with placebo in the treatment of Stress Urinary Incontinence(SUI)(accidental loss of urine due to physical activity such as laughing, coughing or sneezing) in adult female patients aged 50 -75 years.
The purpose of this study is to evaluate the effectiveness and saftey of a single dose of treatment with the study product (AMDC-USR) in treating SUI. The treatment involves having a medical procedure in which the participant’s muscle cells are collected via a biopsy. The cells are then processed and expanded before being injected into the participant's urinary passage. This study will determine if the cells are safe and effective in treating SUI in female adults. The study is comparing treatment with AMDC-USR (injection of participant’s own muscle cells) to a placebo (injection of a solution without cells). All participants will be randomly allocated to either the treatment group or placebo group.
Approximately 320 participants will be enrolled in the study in total with approximately 65 planned to enrol in the UK. Half of participants will receive treatment with AMDC-USR and half will receive the placebo.Participants will be assessed for reduction in stress Incontinence Episode Frequency (IEF) recorded in a Diary at different time points over 2 years following the injection. After 12 months, participants will be unblinded, and participants in the placebo arm will be given the opportunity to receive a single dose of AMDC-USR (open label injection). The study duration is expected to last 2½ years.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
18/LO/1410
Date of REC Opinion
9 Nov 2018
REC opinion
Further Information Favourable Opinion