Cx601-0303 A Phase III, Randomized, 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 Perian

NCT03279081

A Phase III, Randomized, 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.

Associated Conditions

Inflammatory Bowel Disease (IBD)

Principal Investigator

John Monson

Sponsor

TIGENIX

The purpose of this study is to confirm (1) how well the study drug works at a single dose of 120 million cells compared to a placebo; (2) how safe and tolerable the study drug is in patients with fistulizing CD.