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P531. Comparative assessment of the safety of cell and standard anti-inflammatory therapy of ulcerative colitis

O. Knyazev1, A. Parfenov1, I. Ruchkina1, A. Konoplyannikov2, P. Shcherbakov1, R. Gudkova3, L. Lazebnik4, 1Central Research Institute of Gastroenterology, Department of Inflammatory Bowel Disease, Moscow, Russian Federation, 2Medical Radiological Scientific Center, Department of Stem Cells Therapy, Obninsk, Russian Federation, 3Central Research Institute of Gastroenterology, Laboratory of Immunology, Moscow, Russian Federation, 4Moscow State Medico-Dentist University, Department of Therapy, Moscow, Russian Federation

Background

Objective: To compare the safety of treatment of the patients with UC, receiving comprehensive anti-inflammatory therapy with the application of MSCs standard therapy with 5-aminosalicylic acid (5-Asa) and glucocorticosteroids (GSCs).

Methods

Within the period from 2008 to 2013 the system transplantation of allogeneic MSCs was carried out in 74 patients with UC. 56 patients were included in the first group, the average monitoring time averaged 62±4 months. 29 of them (51.78%) were men and 27 (48.22%) women. 84 patients with UC, who received standard anti-inflammatory therapy with 5-Asa and GCSs, were included in the second, control group. Out of them 46 (54.8%) were men and 38 (45.2%) women. The patients, who received anti-cytokine therapy, were not included in this group. The safety of the used therapy was assessed by the presence of complications, arising during the observation, such as infectious complications, exacerbation of chronic inflammatory diseases, serious infectious complications, a malignant transformation, a lethal outcome.

Results

In the first group of patients with UC the development of non-severe infectious complications or exacerbation of chronic inflammatory diseases were registered in 7 patients out of 56, that totaled 12.5%, in the second - in 14 (16.7%) patients out of 84. When comparing the two groups, no differences were found in the risk of the development of infectious complications and exacerbation of chronic inflammatory diseases on the background of the standard anti-inflammatory UC therapy or with the introduction of the MSCs (OR 0.75, 95% CI 1.5–23.58; χ2 0.16; p = 0.66). Severe infectious complications in the first group were detected in 1 patient (1.8%) out of 56, and in the second group in 5 (5.9%) out of 84. When comparing the two groups no differences in the risk of this type of complications were also found (RR 0.3; 95% CI 0.04–2.5; χ2 0.59; p = 0.44). Colorectal cancer was registered only in one she-patient from the first group (1.8%). The time between the introduction of the MSCs and diagnosed colon cancer was 10 days. In the second group of patients over the 5 years of follow-up, malignant transformation was observed in 4 (4.8%) patients out of 84 (RR 0.5, 95% CI 0.05–4.96; χ2 0.01; p = 0.97). Within 5 years of follow-up in the first and second groups of patients, fatal outcomes were registered on one occasion in each group, 1.8% and 1.2% respectively (RR 1.5, 95% CI 0.1–23.49; χ2 0.19, p = 0.66).

Conclusion

No differences in the development of infectious complications, exacerbation of chronic inflammatory diseases, serious infectious complications of malignant transformations and deaths in patients with UC, who received the MSCs and the standard anti-inflammatory therapy.