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* = Presenting author

P592 Comparative assessment of the safety of stem cells and standard anti-inflammatory therapy of Crohn's Disease

O. Knyazev1, A. Kagramanova*1, A. Parfenov1, I. Ruchkina1, A. Konoplyannikov2, A. Churikova1

1Moscow Clinical Research Center, Department of Inflammatory Bowel Disease, Moscow, Russian Federation, 2Medical Radiological Scientific Center, Department of Stem Cells Therapy, Obninsk, Russian Federation

Background

Mesenchymal stromal cells (MSCs) are now widely used in clinical studies with various diseases, providing a positive effect due to the immunomodulatory and paracrine mechanisms.

Objective: to compare the safety of treatment of the patients with Crohn's disease (CD), receiving comprehensive anti-inflammatory therapy with the application of MSCs standard therapy with 5-aminosalicylic acid (5-ASA), glucocorticosteroids (GSCs) and immunosuppressive agents (IS).

Methods

Within the period from 2008 to 2013 the system transplantation of allogenic MSCs was carried out in 64 patients with CD. 47 patients were included in the first group. 124 patients with CD, who received standard anti-inflammatory therapy were included in the second group. The patients, who received anti-cytokine therapy, were not included in this group.

Results

In the first group of patients with CD 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 CD therapy or with the introduction of the MSCs (RR-0.75, 95% Cl 1.5-23.58; x2-0,16; p=0.66). Severe infectious complications (pneumonia, pleurisy, activation of latent TB) 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% Cl 0.04-2.5; x2-0.59; 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% Cl 0.05-4.96; x2-0.01; 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% Cl 0.1-23.49; x2-0.19, p=0.66).

Conclusion

The analysis did not reveal any differences in the development of severe infectious complications, exacerbation of chronic inflammatory diseases, serious infectious complications of malignant transformations and deaths in patients with CD, who received the MSCs and the standard anti-inflammatory therapy.