Liming Wang,1,* Shigao Huang,2,* Shimei Li,1 Ming Li,1 Jun Shi,1 Wen Bai,1 Qianyun Wang,1 Libo Zheng,3 Yongjun Liu3

1Cell Therapy Center, 986 Hospital of Peoples Liberation Army Air Force, Xian, Shaanxi, Peoples Republic of China; 2Cancer Center, Institute of Translational Medicine, Faculty of Health Sciences, University of Macau, Taipa, Macao SAR, Peoples Republic of China; 3Stem Cell Biology and Regenerative Medicine Institution, Yi-Chuang Institute of Bio-Industry, Beijing, Peoples Republic of China

*These authors contributed equally to this work

Correspondence: Shigao HuangCancer Center, Institute of Translational Medicine, Faculty of Health Sciences, University of Macau, Room 3013, Building N-22, Taipa, Macau, Peoples Republic of ChinaEmail huangshigao2010@aliyun.comYongjun LiuStem Cell Biology and Regenerative Medicine Institution, Yi-Chuang Institute of Bio-Industry, No. 35, Jinghai 3 Road Economic-Technological Development Area, Beijing, Peoples Republic of ChinaEmail andyliuliu2001@aliyun.com

Background: The traditional anti-inflammation disease-modifying anti-rheumatic drugs (DMARDs) have limited therapeutic effects in rheumatoid arthritis (RA) patients. We previously reported the safety and efficacy of umbilical cord mesenchymal stem cell (UC-MSC) treatment in RA patients that were observed for up to 8 months after UC-MSC infusion. The aim of this study is to assess the long-term efficacy and safety of UC-MSC along with DMARDs for the treatment of RA.Methods: 64 RA patients aged 1864 years were recruited in the study. During the treatment, patients were treated with 40 mL UC-MSC suspension product (2 107 cells/20 mL) via intravenous injection immediately after the infusion of 100 mL saline. The serological markers tests were used to assess safety and the 28-joint disease activity score (DAS28) and the Health Assessment Questionnaire (HAQ) to assess efficacy.Results: 1 year and 3 years after UC-MSC cells treatment, the blood routine, liver and kidney function and immunoglobulin examination showed no abnormalities, which were all in the normal range. The ESR, CRP, RF of 1 year and 3 years after treatment and anti-CCP of 3 years after treatment were detected to be lower than that of pretreatment, which showed significant change (P < 0.05). Health index (HAQ) and joint function index (DAS28) decreased 1 year and 3 years after treatment than before treatment (P < 0.05).Conclusion: UC-MSC cells plus DMARDs therapy can be a safe, effective and feasible therapeutic option for RA patients.

Keywords: rheumatoid arthritis, umbilical cord mesenchymal stem cell, cell therapy

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