P413 Relative frequency of relapses in patients with ulcerative colitis and Crohn's disease treated with mesenchymal stromal cells: Five-years of follow-up

Abstract

Background: Numerous studies have shown that mesenchymal stromal cells (MSCs) have a high potential for differentiation and immunosuppressive properties. Currently under phases I‐III clinical trials evaluating the efficacy and safety of MSCs in the treatment of patients with inflammatory bowel disease (IBD)‐ulcerative colitis (UC) and Crohn's disease (CD). To compare the frequency of relapses and duration of remission for 5 years of follow‐up in patients with luminal Crohn's disease (CD) and the total defeat of ulcerative colitis (UC) receiving therapy with mesenchymal stromal cells (MSCs) and bone marrow. Methods: We compared the frequency of relapses in patients with luminal form CD (colitis and ileokolit), with a group of patients with UC (total lesion) receiving MSCs. A group of patients (CD) aged 22‐56 years (Me‐28) (n = 24) received MSC culture scheme (0‐1‐2 weeks, then every 26 weeks). The second group of patients with UC (n = 26) aged 20‐62 years (Me‐28) received the culture of MSCs in a similar way. Evaluation of the effectiveness of therapy for relapse frequency was carried out at 12, 24, 36, 48, and 60 months after initiation of therapy. Results: Among the patients in first group relapse in the 12 months of observation occurred in 2 of 24 patients (8.3%) in 2 group, relapse occurred in 3 of 26 (11.5%) (OR‐0.72; 95% CI 0.13‐3.96, p = 0.92). After 24 months in the group of patients (group 1) receiving MSC, relapse occurred in 5 of 24 (20.8%) in group 2 patients with recurrent disease in 7 of 26 (26.9%) (OR‐0.77; 95% CI 0.13‐3.96, p = 0.92). After 36 months in group 1 patients with a relapse of the disease in 8 of 24 (33.3%) in group 2 relapsed in 14 of 26 (53.8%) (OR‐0.62; 95% CI 0.32‐1.21; p = 0.24). After 48 months in group 1 receiving MSC, relapsed in 11 of 24 (45.8%) in group 2 relapsed in 18 of 26 (69.2%) (OR‐0.6; 95% CI 0.37‐0.97, p = 0.048). After 60 months in first relapse in 16 of 24 (66.6%) in group 2 relapsed in 22 of 26 (84.6%) (OR‐0.63; 95% CI 0.44‐0 90, p = 0.013). Conclusions: MSCs transplantation longer contributes to clinical remission in patients with Crohn's disease luminal shape compared with a group of patients suffering from ulcerative colitis.