Effects and Safety of Allogenic Mesenchymal Stem Cell Intravenous Infusion in Active Ankylosing Spondylitis Patients who Failed NSAIDs: A 20-Week Clinical Trial

Abstract

Our objective was to evaluate the feasibility, safety, and efficacy of intravenous (IV) infusion of allogenic mesenchymal stem cells (MSCs) in ankylosing spondylitis (AS) patients who are refractory to or cannot tolerate the side effects of nonsteroidal anti-inflammatory drugs (NSAIDs). AS patients enrolled in this study received four IV infusions of MSCs on days 0, 7, 14, and 21. The percentage of ASAS20 responders (the primary endpoint) at the fourth week and the mean ASAS20 response duration (the secondary endpoint) were used to assess treatment response to MSC infusion and duration of the therapeutic effects. Ankylosing Spondylitis Disease Activity Score Containing C-reactive Protein (ASDAS-CRP) and other preestablished evaluation indices were also adopted to evaluate the clinical effects. Magnetic resonance imaging (MRI) was performed to detect changes of bone marrow edema in the spine. The safety of this treatment was also evaluated. Thirty-one patients were included, and the percentage of ASAS20 responders reached 77.4% at the fourth week, and the mean ASAS20 response duration was 7.1 weeks. The mean ASDAS-CRP score decreased from 3.6 ± 0.6 to 2.4 ± 0.5 at the fourth week and then increased to 3.2 ± 0.8 at the 20th week. The average total inflammation extent (TIE) detected by MRI decreased from 533,482.5 at baseline to 480,692.3 at the fourth week (p > 0.05) and 400,547.2 at the 20th week (p < 0.05). No adverse effects were noted. IV infusion of MSCs is a feasible, safe, and promising treatment for patients with AS.

Autophagy Improves the Immunosuppression of CD4+ T Cells by Mesenchymal Stem Cells Through Transforming Growth Factor-β1

“…MSCs have been applied to treat many autoimmune and inflammatory diseases, such as graft-versus-host disease (GVHD) [15], Crohn's disease [16], and ankylosing spondylitis [17]; these applications depended on the immunomodulatory effects and low host immune reactivity of these cells [18]. However, the individual treatment efficacy of these cells is currently varied and very limited, and the underlying mechanisms that affect the treatment efficacy are poorly understood.…”

Mesenchimal stem cells: a possible role in the pathogenesis and treatment of spondyloarthritis

“…The authors stated that intravenous infusion of MSCs is a feasible, safe, and promising treatment for patients with AS. However, this study had some limitations such as the lack of a control group, the small number of enrolled patients and the lack of assessment of radiographic progression (70). …”

Stem Cell Transplantation as a Possible Strategy for Treating Standard Therapy-Resistant Ankylosing Spondylitis

“…Суммарно описано четыре ТСК больным АС, из них в 1 случае трансплантация выполнена больному с сочетанием лимфомы и АС [12], в 2 случаях -больным АС без онкоге-матологических заболеваний [13,14], в 1 случае -пациенту с сочетанием АС и миелоидного лейкоза [15]. У 3 больных АС достигнута безлекарственная ремиссия [12,13,15]: у больного с сочетанием лимфомы и АС, у пациента с соче-танием АС и миелоидного лейкоза и у больного АС без со-путствующих заболеваний.…”

“…Аллогенная ТСК, при которой пациенту вводится ко-стный мозг или стволовые клетки периферической крови от родственного или неродственного совместимого донора, применялась в 2 случаях [14,15], аутологичная трансплан-тация, при которой реципиент получает предварительно заготовленный собственный костный мозг или гемопоэти-ческие клетки периферической крови -также в 2 случаях [12,13].…”