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P485 The combined of mesenchymal stem cells and infliximab reduces the recurrence rate of Crohn’s disease

O. Knyazev1, N. Fadeeva*2, A. Kagramanova1, P. Shcherbakov3, I. Ruchkina1, A. Parfenov1, A. Konoplyannikov4

1Moscow Clinical Research Centre, Department of Inflammatory Bowel Disease, Moscow, Russian Federation, 2Moscow Clinical Research Centre, Department of Inflammatory bowel disease, Moscow, Russian Federation, 3Central Research Institute of Gastroenterology, Department of Inflammatory Bowel Disease, Moscow, Russian Federation, 4Medical Radiological Scientific Centre, Department of Stem Cells Therapy, Obninsk, Russian Federation

Background

One of the predictors of relapse-free course of Crohn’s disease (CD) is a complete healing of the intestinal mucosa. Anticytokine therapy with anti-TNF-α drugs contributes to the clinical and endoscopic remission CD. One of the promising new therapies is also a CD cell therapy with mesenchymal stem cells (MSC) of the bone marrow. In some cases, together with the MSC, patients receiving concomitant immunosuppressive therapy. It is found that immunomodulatory drugs (azathioprine, methotrexate, 6-mercaptopurine, infliximab), regardless of the concentration, do not affect the viability, differentiation, phenotype, and the ability to inhibit proliferation of MSCs peripheral blood mononuclear cells. These results are important for clinical applications in combination with MSCs immunosuppressive and anti-TNF-α therapy. At the present time it has not been studied clinical efficacy of combined use of mobility shift assay (MSA) and anti-TNF-α drugs in the treatment of patients with CD.

Objective: to study the effect of combination therapy of mesenchymal stem cells (MSCs), bone marrow, and infliximab (IFX) in the relapse rate of Crohn’s disease.

Methods

In total, 67 patients with CD in the form of colitis and ileokolitis divided into 3 groups. The first group of patients, aged 19 to 58 years old (Me-29) (n = 21), received standard anti-inflammatory therapy with 5-aminosalicylic acid (5-ASA), glucocorticosteroids (GCS) and immunosuppressive (IS) + culture MSCs. The second group of patients with CD (n = 30), aged 20 to 68 years (Me-32), received therapy anticytokine IFX. A third group of patients with CD (n = 16) aged 20 to 62 years old (Me-28) received therapy anticytokine IFX + culture MSCs. Monitoring is carried out at 12, 24, and 36 months after initiation of therapy. Relapse rates were evaluated using percentage and 95% confidence interval.

Results

Amongst the first group of patients relapse within 12 months of observation occurred in 1/21 patients (4.76%). In the second group of patients relapse occurred in 3/30 (10.0%) of 30 patients with CD within 12 months of follow-up (p = 0.87). In the third group relapse were observed (0/16) (p = 0.54). After 24 months in the first group of patients receiving MSC, relapse occurred in 4/21 (19.0%). In the second group of patients relapse occurred in 6/30 (20.0%) (p = 0.78). In the third group relapse occurred in one patient 1/16 (6.25%) (p = 0.39). After 36 months, in the first group of patients, relapse occurred in 7/21 (33.3%). In the second group of patients, relapse occurred in 11/30 (36.6%) (p = 0.95). In the third group, relapse occurred in one patient 1/16 (6.25%) (p = 0.03).

Conclusion

The anti-inflammatory combined therapy cell and anticytokine therapy of Crohn’s disease significantly reduces relapse within 3 years of observation.