脐带间充质干细胞治疗类风湿关节炎临床大样本研究（附原文）

jihaijie

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Stem Cells Dev. 2013 Aug 13. [Epub ahead of print]
$ V0 N( Z& _" q% l1 hHuman Umbilical Cord Mesenchymal Stem Cell Therapy for Patients with Active Rheumatoid Arthritis: Safety and Efficacy.
: A8 q* k" s* W5 k% f6 tWang L, Wang L, Cong X, Liu G, Zhou J, Bai B, Li Y, Bai W, Li M, Ji H, Zhu D, Wu M, Liu Y.
% E, U8 F6 x) n: Y5 u0 M1 \& LSource323 Hospital of Chinese People's Liberation Army, Cell Therapy Center, xi'an, Shanxi , China ; wanglm@fmmu.edu.cn.
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Abstract
0 y* a- Z. `3 I) r+ H  BThis study was designed to assess the safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) in the treatment of rheumatoid arthritis (RA). In this ongoing cohort, 172 patients with active RA who had inadequate responses to traditional medication were enrolled. Patients were divided into two groups for different treatment: Disease modifying anti-rheumatic drugs (DMARDs) plus medium without UC-MSCs, or DMARDs plus UC-MSCs group (4×107 cells per time) via intravenous injection. Adverse events and the clinical information were recorded. Tests for serological markers to assess safety and disease activity were conducted. Serum levels of inflammatory chemokines/cytokines were measured and lymphocyte subsets in peripheral blood were analyzed. No serious adverse effects were observed during or after infusion. The serum levels of tumor necrosis factor-alpha and interleukin-6 decreased after the first UC-MSCs treatment (p<0.05). The percentage of CD4+CD25+Foxp3+ regulatory T cells of peripheral blood was increased (p<0.05). The treatment induced a significant remission of disease according to the American College of Rheumatology improvement criteria, the 28-joint disease activity score, and the Health Assessment Questionnaire. The therapeutic effects maintained for 3-6 months without continuous administration, correlating with the increased percentage of regulatory T cells of peripheral blood. Repeated infusion after this period can enhance the therapeutic efficacy. In comparison, there were no such benefits observed in control group of DMARDS plus medium without UC-MSCs. Thus our data indicate that treatment with DMARDs plus UC-MSCs may provide safe, significant and persistent clinical benefits for patients with active RA.
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8楼原文 感谢ruofan1982 提供

helong

advertisment or adervocacy?

mrsci

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类风湿关节炎是自身免疫性疾病，而MSC具有调节免疫的作用，这些都基本有定论，因此MSC能在一定程度上治疗或缓解RA，这是完全可能的。这个数据应该是可信的。* T5 w# f3 d: Q& `" Z
是不是广告并不重要，关键是SFDA如何管理这些临床治疗或研究。干细胞治疗作为一种全新治疗技术，其前景无限，世界各国都在暗自较劲，而我们的政策还在摇摆不定，还在征求意见。- M8 Z5 `( m. u8 r! z9 m
**总是不作为，下面就只好瞎作为了。

一转身的距离

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uslzhang

试验

uslzhang

可惜了，这么大一个临床试验不是双盲+空白对照试验，RA这个选题不错，加上这么大的试验规模，如果设计好了就更具有说服力，结果也更加可信，完全有可能上New England J. of Medecine（影响因子20+）。

uslzhang

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ruofan1982

全文

zjdoctor

这是个了不起的工程，我们也在做这样的工作，尤其RA和SLE，疗效都不错，就是，注册、申报、得到认可，尤其国外同行，我们就是领先的。自身免疫性疾病是我们的一个突破口，这方面同志们需要一些文献我可以无偿提供。也可以自己在网上搜索。$ v, ~( p8 u6 K- G- {2 ^% z
感谢细胞海洋的工作，还有各位最新进展的提供者。以后多交流。目前肝硬化、肝纤维化、SLe，干细胞注射液已经被药监局接受了，我估计不久就会出台相关的临床研究规范。局面还算是大好吧。坚持啊。

jihaijie

全文终于出来了，上传和大家分享。