ADMIRE-CD II study.
Research type
Research Study
Full title
A phase III, randomised, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.
IRAS ID
254458
Contact name
Kate Smoter
Contact email
Sponsor organisation
TiGenix, S.A.U
Eudract number
2017-000725-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 27 days
Research summary
Crohn’s disease (CD) is a chronic (persisting for a long time), inflammatory process of the bowel with unknown cause, that often leads to scarring and obstructive symptoms and can affect any part of the gastrointestinal (stomach and intestines) tract from the mouth to the anus, believed to be the result of an imbalance between pro-inflammatory (promote inflammation) and anti-inflammatory (supress inflammation) processes. This results in thickening of the bowel wall and narrowing of the lumen, and as CD progresses, it is complicated by obstruction or deep ulceration leading to fistulisation, abscess formation (collection of pus in the anus or around the anus), adhesions (fibrous bands form between tissues and organs), and malabsorption (abnormality in absorption of food).
CD´s subjects are invited to participate in a study to investigate whether a new drug called Cx601 can help treat complex perianal fistulas (tunnels which can form and connect the anal canal to the surface of the skin nearby). Cx601 is a solution containing human expanded adipose-derived stem cells obtained from healthy donors. Cx601 has shown the potential to aid the immune system in some non clinical studies.
This study is to confirm how well Cx601 works compared to placebo (inactive drug) and how safe and tolerable it is.
To make this comparison as fair as possible, this study is “double blinded”. Meaning that neither the participant nor the study doctor will know whether they are receiving Cx601 or placebo. Which treatment the participant will be given will be decided randomly (like tossing a coin). Participants will be in the study approximately 15 months, which consists of 9 study visits. The study will involve at least 326 participants and will be conducted at approximately 150 hospitals in the United States of America, Canada, the European Union, and Israel. The study is sponsored by TiGenix.REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/2087
Date of REC Opinion
17 Apr 2019
REC opinion
Further Information Favourable Opinion