【摘 要】
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Background: Mesenchymal stem cells (MSCs) are a potentially novel treatment of autoimmune diseases.The goal of this current study is to assess safety and efficacy of human umbilical cord MSCs (UC-MSCs
【机 构】
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Cell Therapy Center, 323 Hospital of Chinese People's Liberation Army, Xi'an, 710054, China
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Background: Mesenchymal stem cells (MSCs) are a potentially novel treatment of autoimmune diseases.The goal of this current study is to assess safety and efficacy of human umbilical cord MSCs (UC-MSCs) for treatment of severe and refractory rheumatoid arthritis (RA).Methods: Since January, 2011, 137 patients were enrolled and treated twice by intravenous infusion of 4× 107UC-MSCs, 24 patients were treated three times among them.The treatment related adverse events and the clinical information were recorded.Tests for serological markers to access safety and disease activity were conducted at various time points.Additionally, serum levels of inflammatory chemokines/cytokines were measured and lymphocyte subsets in peripheral blood were assessed by flow cytometry.Results: No serious adverse effects were observed during or after infusion of the allogeneic UC-MSCs.Treatment with UC-MSCs led to significant reductions in disease activity measured by the American College of Rheumatology (ACR) improvement criteria, the 28-joint disease activity score (DAS28), and the Health Assessment Questionnaire (HAQ).The serum levels of TNF-α and IL-6 were reduced after the treatments (P<0.05).Furthermore, the percentage of CD4+CD25+Foxp3+regulatory T cells (Tregs)in the peripheral blood was significantly increased (P<0.05, before vs.after).Interpretation: Data from the current cohort indicate that the UC-MSCs infusion is safe and effective.The potent anti-inflammation and immune-modulatory effects resulting from UC-MSC may provide significant and persistent clinical benefits for patients with RA.Larger cohorts are needed to confirm this finding in the future.
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