Crohn Disease Clinical Trial
Official title:
Randomized, Single-blind, Placebo Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Expanded Autologous Adipose-derived Stem Cells (ASCs) (CX-401), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease
The purpose of this study is to determine safety and efficacy of eASCs (expanded adult stem cells) for treatment of complex perianal fistulas in patients with Crohn's disease.
Complex perianal fistulas are a source of great distress for suffers. In Crohn's disease,
options are limited, and surgery is often associated with incontinence and recurrence.
The biological properties of stem cells derived from adult tissues make them candidates for
the treatment of pathologies requiring tissue regeneration or in diseases where the healing
process is altered.
A proof-of-concept study, a phase 1 study and a phase 2 study [Clinicaltrials.gov identifier:
NCT00115466] have all suggested that this approach is promising, even in patients whose
fistula is associated with Crohn's disease.
The present multicenter, placebo-controlled, phase 3 study aims to confirm the efficacy and
safety shown in the previous phase 1 and phase 2 studies in the treatment of complex perianal
fistulas in patients with Crohn's disease after 24 weeks from initial administration. Fistula
closure is defined as absence of suppuration through the external orifice with complete
re-epithelization of the external orifice and absence of collections >2cm directly related to
the fistula tract treated, as measured by MRI.
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