Crohn's Disease Clinical Trial
Official title:
Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulas in Patients With Refractory Perianal Crohn's Disease
In a dose escalation study we will determine the safety and preliminary efficacy of allogeneic bone marrow mesenchymal stem cells (bmMSCs) in the induction of response for active fistulizing Crohn's Disease (CD).
Despite the introduction of anti-TNFa (tumor necrosis factor alpha) therapy, perianal
disease still accounts for a high rate of morbidity in patients diagnosed with CD. Recently,
a phase II multicenter randomized study was reported showing that expanded adipose tissue
derived mesenchymal stem cells (atMSCs) in combination with fibrin glue was an effective and
safe treatment for complex perianal fistula. However, dose escalation of allogeneic bone
marrow (bm) MSCs for the local treatment of perianal fistulas has not been studied.
In this study, three escalating doses will be tested in a total of three cohorts. MSC
implantation will be preceded by surgical localization, curettage of the fistulous tract and
closure of the internal opening. Per cohort, patients will be randomized in a 5:2 fashion to
receive either 10x10^6 (cohort 1), 30x10^6 (cohort 2) or 90x10^6 (cohort 3) bmMSCs or no
cells (control group).
The primary endpoint will be assessed at week 12: i) the number of adverse and serious
adverse events and ii) a reduction in the number of draining fistulas, which is defined as
absence of discharge and absence of collections of ≥2 cm directly related to the treated
fistulas tracts as measured by MRI.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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