バイオテクノロジーとバイオマテリアル

抽象的な

Safety of Mesenchymal Stem Cells Therapy in Patients with Inflammatory Bowel Diseases 5 Year Follow-Up

Knyazev Oleg Vladimirovich, Parfenov Asfold Ivanovich, Konoplaynnikov Anatoliy Georgievich, Kagramanova Anna Valeryevna, Churikova Alevtina Alekseevna, Ruchkina Irina Nikolaevna, Lishinskaya Albina Aleksandrovna, Boldireva Oksana Nikolaevna and Fadeeva Nina Aleksandr

Aim: To compare safety profile of therapy in patients with ulcerative colitis (UC) and Crohn disease (СD), receiving anti-inflammatory therapy, using bone marrow-derived mesenchymal stromal cells (MSC) and standard therapy with 5-aminosalicylic acid (5-ASA), glucocorticosteroids (GCS) and immunosuppressive agents (IS).

Materials and methods: Adverse events were analyzed in 103 patients with inflammatory bowel disease (IBD) after administration MSCs (56 patients UC and 47 patients CD). The findings were compared with data obtained in 208 patients with UC and CD, receiving standard anti-inflammatory therapy. All analyzed patients were similar in demographic characteristics, the duration of disease, the extent of disease, course of disease, phenotype and degree of disease. The analyzed groups did not include patients, treated with anti-TNF therapy. The safety of therapy was evaluated by presence of complications, developed during follow-up period.

Results: We conducted analysis of side effects in 103 IBD patients, treated with mesenchymal stem cells, comparing with 208 UC and CD patients, treated with standard anti-inflammatory therapy and finally we did not reveal any differences in developing acute post-transfusional toxicity, infectious complications, exacerbation of chronic inflammatory diseases, serious infectious complications, malignancy and death in UC and CD patients, besides transitive febrile.

Conclusion: Results of our study show that innovative method of cell therapy is safe in clinical practice.