title: 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.
authors.affiliation: Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, P. R. China.
authors.forename: Peng
authors.initials: P
authors.lastname: Wang
authors.forename: Yuxi
authors.initials: Y
authors.lastname: Li
authors.forename: Lin
authors.initials: L
authors.lastname: Huang
authors.forename: Jiewen
authors.initials: J
authors.lastname: Yang
authors.forename: Rui
authors.initials: R
authors.lastname: Yang
authors.forename: Wen
authors.initials: W
authors.lastname: Deng
authors.forename: Biling
authors.initials: B
authors.lastname: Liang
authors.forename: Lie
authors.initials: L
authors.lastname: Dai
authors.forename: Qingqi
authors.initials: Q
authors.lastname: Meng
authors.forename: Liangbin
authors.initials: L
authors.lastname: Gao
authors.forename: Xiaodong
authors.initials: X
authors.lastname: Chen
authors.forename: Jun
authors.initials: J
authors.lastname: Shen
authors.forename: Yong
authors.initials: Y
authors.lastname: Tang
authors.forename: Xin
authors.initials: X
authors.lastname: Zhang
authors.forename: Jingyi
authors.initials: J
authors.lastname: Hou
authors.forename: Jichao
authors.initials: J
authors.lastname: Ye
authors.forename: Keng
authors.initials: K
authors.lastname: Chen
authors.forename: Zhaopeng
authors.initials: Z
authors.lastname: Cai
authors.forename: Yanfeng
authors.initials: Y
authors.lastname: Wu
authors.forename: Huiyong
authors.initials: H
authors.lastname: Shen
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods*; D059630:Mesenchymal Stem Cells / Q000166:cytology; D013167:Spondylitis, Ankylosing / Q000188:drug therapy / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal