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P352. The effectiveness and safeness of allogeneic mesenchymal bone marrow stromal cells in patients with refractory Crohn's disease – 5 years of observation

O. Knyazev1, P. Shcherbakov1, A. Parfenov1, I. Ruchkina1, A. Konoplyannikov2, L. Lazebnik3, 1Central Research Institute of Gastroenterology, Moscow, Russian Federation, 2Medical Radiological Research Center, Obninsk, Russian Federation, 3Clinical Hospital 33 of Moscow City, Moscow, Russian Federation

Background

The frequency of exacerbations Crohn's disease (CD) is approximately 20–25% at 1 year and 75% for 3 years.

Aim: To evaluate the influence of culture of allogeneic mesenchymal stromal cells (MSCs) of bone marrow for the duration of remission on patients with refractory CD after 5 years.

Methods

The 1-st group of patients with CD (n = 30) received MSCs, the dose of prednisone was not more than 20 mg/day. The 2-nd group of patients (n = 30) received standard anti-inflammatory drug therapy. Age of patients – 19 to 49 years (Me-36). The disease was of moderate and high. The observation time ranged from 42 to 68 months. Clinical activity was assessed by the Crohn's disease activity index (CDAI). The culture of MSCs injected drip at 2.5 million per 1 kg of body weight.

Results

CDAI in the 1-st group was 242.6±11.7 points, in the 2-nd 240.9±12.9 points (pts) (p = 0.83), CRP levels in 1-st group was 29.3±6.4 mg/l, the 2-nd – 27.8±4.8 (p = 0.47). After 1 year of follow-CDAI in 1-st group was 70.0±11.0 pts, in the 2-nd – 133.8±22.2 pts (p < 0.001), CRP levels in 1-st group was 6.36±1.5 mg/l, in the 2-nd – 12.2±2.9 (p < 0.001). After 2 years CDAI 1-st group was 99.6±19.3 pts, in the 2-nd – 147.1±22.1 pts (p < 0.001), CRP levels in 1-st group was 16.0±6.0 mg/l, in the 2-nd – 18.8±4.4 (p = 0.156). After 3 years, the CDAI in 1-st group was 110.5±21.9 pts, in the 2-nd – 180.6±20.3 pts (p < 0.001), CRP levels in 1-st group was 10.9±2.6 mg/l, in the 2-nd – 16.9±3.0 (p < 0.001). After 4 years – the CDAI in 1-st group was 120.0±22.3 pts, in the 2-nd – 208.7±17.6 pts (p < 0.001), CRP levels in 1-st group was 11.3±2.6 mg/l, in the 2-nd – 15.5±2.4 (p < 0.001). After 5 years – the CDAI in 1-st group was 126.0±23.8 pts, in the 2-nd – 248.7±14.6 pts (p < 0.001), CRP levels in 1-st group was 12.3±2.8 mg/l, in the 2-nd – 19.5±3.1 (p < 0.001). In the 1-st group of patients in remission after 1, 2, 3, 4, and 5 years was kept at 70%, 56.6%, 50%, 46.7% and 43.3%, respectively. In the second group of patients at 1, 2, 3, 4, and 5-year remission was maintained at 36.6%, 26.6%, 13.3%, 6.67% and 6.67%, respectively. Complete healing of mucosa in 60% of patients in the 1-st group during the 1-st year of observation, after 5 years – 26.7%. Over the entire period of observation never there were no malignant transformations, life-threatening infectious complications and death.

Conclusion

Transplantation of MSCs contributes to longer-term clinical and endoscopic remission in patients with refractory Crohn's disease compared with therapy with corticosteroids.