EUCTR2017‐000725‐12‐CZ.

Study name	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.
Methods	A phase III, randomised, double‐blind, parallel group, placebo‐controlled,international, multicentre study.
Participants	Targeted sample: 554 Patients of either gender = 18 years and =75 years of age Patients with Crohn’s disease diagnosed at least 6 months prior to screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria with complex perianal fistula(s)
Interventions	Cx601, adult allogeneic expanded adipose‐derived stem cells (eASC) 5 million cells/ml suspension for injection CX601
Outcomes	Primary end point(s): proportion of participants who achieve combined remission at week 24 after IMP administration, where combined remission is defined as: ‐ The closure of all treated external openings that were draining at baseline despite gentle finger compression AND ‐ Absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central MRI assessment.
Starting date	Date of first enrolment:08/08/2017
Contact information	C/ Marconi 1. Parque Tecnológico de Madrid 28760 Madrid Spain +3491804 92 64 inmaculada.gilaberte@takeda.com
Notes	Authorised‐recruitment may be ongoing or finished Source(s) of Monetary Support: TiGenix S.A.U. other ID registries: NCT03279081