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BACKGROUND & AIMS: Patients with perianal fistulizing Crohn's disease have a poor prognosis because these lesions do not heal well. We evaluated the effects of local administration of bone marrow-derived mesenchymal stromal cells (MSCs) to these patients from healthy donors in a double-blind, placebo-controlled study. METHODS: Twenty-one patients with refractory perianal fistulizing Crohn's disease were randomly assigned to groups given injections of 1 x 10(7) (n = 5, group 1), 3 x 10(7) (n = 5, group 2), or 9 x 10(7) (n = 5, group 3) MSCs, or placebo (solution with no cells, n = 6), into the wall of curettaged fistula, around the trimmed and closed internal opening. The primary outcome, fistula healing, was determined by physical examination 6, 12, and 24 weeks later; healing was defined as absence of discharge and

G A A b st ra ct s that patients require higher doses of IFX than standard induction dosing in Acute Severe UC to achieve therapeutic levels. By delivering IFX at shorter intervals during induction, higher trough levels could be achieved, and patients could be successfully treated medically without the need for colectomy. Methods Retrospective analysis of a prospectively maintained database of patients with IBD (n=3,200). Patients who required hospitalisation and were given rescue infliximab for acute severe colitis from June 2005-September 2013 at a single academic centre were identified. In 2011 an accelerated dosing protocol for IFX was introduced. Patients given standard dosing (SD) received IFX at time 0, 2, and 6 weeks and 8 weekly thereafter. Patients given accelerated dosing (AD) received all three induction doses of IFX within 2 weeks and 8 weekly thereafter. Rates of colectomy were compared between the 2 groups at 3,6 and 12 months. Results 52 patients received rescue infliximab; 38 received SD and 14 received AD. There were no differences in median CRP (SD= 54, AD= 38 p=0.4), median albumin (SD=23, AD=22.5, p=0.64), median platelet count (SD=390, AD=414, p=0.84), median haemoglobin(11.0 SD, 10.5AD p=0.76) or median disease duration (SD=11.8 years, AD=5.3 years, p=0.47) between the 2 groups on the day of induction. 18/38 (47.3%) required surgery in the standard regimen and 4/14 (28.5%) in the accelerated regimen during follow-up. Rate of colectomy at 3 months was significantly lower with AD versus SD; 1/14 (7.1%) vs 14/38 (36.8%), fisher exact test p=0.04. A trend toward reduced colectomy rate remained at 6 months; 2/14 (14.3%) versus 14/38 (36.8%), p=0.18. At 12 months colectomy rates were more comparable; 4/14(29%) versus 15/38 (39%), p=0.53. Conclusion Use of an accelerated induction regimen with IFX is protective against early colectomy in acute severe colitis. These findings suggest that higher IFX doses may be required in severe colitis due to high levels of TNFα and more rapid drug clearance. A more aggressive dosing strategy, guided by measurement of IFX levels, may assist in maintaining early success in avoiding colectomy. Patient Demographics and Outcomes