Background: New treatments for Crohn's disease (CD) is a biologic therapy using mesenchymal stromal cells (MSCs) of the bone marrow. In some cases, together with the MSC, patients receiving concomitant immunosuppressive therapy. The aim of our work was to study the effect of the combined use of bone marrow MSCs and azathioprine (AZA) on the clinical course of CD.
Methods: 34 patients with BC luminal form divided into two groups. The first group of patients aged 19 to 58 years old (Me-29) (n=15) was treated with anti-inflammatory therapy with MSCs culture 2 million cells/kg+AZA 2 mg/kg. The second group of patients with CD (n=19) aged 23 to 60 years old (Me-31) received MSCs according to the recommended scheme (without AZA). Culture MSCs were injected three times a month at intervals of 1 week after 6 months from the date of the first administration of MSCs. The initial average index of activity of Crohn's disease (CDAI) in the first group amounted to 337.6±17.1 points, the second group – 332.7±11.0 points (p=0.3). Evaluation of efficacy was performed at 12, 24 and 36 months.
Results: After 12 months in the first group of patients relapse occurred in CD 1 (6.6%) patient, the second – in 2 (10.5%) (OR- 0.63; 95% CI 0.06–6.34, p=0.82). Middle CDAI in the first group of patients – 99.9±10.8 points, the second – 100.6±12.1 points (p=0.8). After 24 months in the first group of patients with relapsed CD occurred in 3 patients (20.0%), the second – in 4 (21.05%) (OR- 0.95; 95% CI 0.25–3.61, p=0.72). Middle CDAI in the first group of patients with CD was 133.2±28.3 points, the second – 120.8±15.5 points (p=0.2). Through 36 months in the first group of patients with CD relapse occurred in 5 (33.3%) patients with CD, the second – in 6 (31.6%) (OR-1.06; 95% CI 0.4–2.8, p=0.79). Middle CDAI in the first group of patients with CD was 139.9±23.4 points, the second – 141.7±20.8 points (p=0.9).
Conclusions: During three years of follow up in patients treated with MSCs and AZA, and in patients receiving only MSCs, there was no difference in the frequency of relapses and CD clinical activity.