T cell vaccination benefits relapsing progressive multiple sclerosis patients: a randomized, double-blind clinical trial.
T cell vaccination benefits relapsing progressive multiple sclerosis patients: a randomized, double-blind clinical trial.
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DOI：
10.1371/journal.pone.0050478
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发表时间：
2012
期刊：
影响因子：
3.7
通讯作者：
Abulafia-Lapid R
中科院分区：
文献类型：
--
作者：
Karussis D;Shor H;Yachnin J;Lanxner N;Amiel M;Baruch K;Keren-Zur Y;Haviv O;Filippi M;Petrou P;Hajag S;Vourka-Karussis U;Vaknin-Dembinsky A;Khoury S;Abramsky O;Atlan H;Cohen IR;Abulafia-Lapid R
用于治疗多发性硬化症 (MS) 的 T 细胞疫苗接种 (TCV) 是指使用通过辐射减弱的自体抗髓磷脂 T 细胞进行治疗。此前发表的临床试验均是开放标签的。在一项双盲对照临床试验中评估 TCV 在进展性多发性硬化症中的安全性和有效性。 26 名复发进展型多发性硬化症患者参与了该研究（平均年龄：39±9.8 岁；平均 EDSS：4.4±1.7）。对髓磷脂抗原、MBP、MOG 和 PLP 的 9 种不同肽有反应的 T 细胞系是从患者的外周血中培养出来的。患者被随机分为两组：19 名患者接受 TCV 治疗（在第 1、30、90 和 180 天皮下注射 4 次 10-30×106 T 细胞，通过照射减毒），7 名患者接受假注射治疗。 24 名患者（TCV 组 17 名，安慰剂组 7 名）符合符合方案分析的条件。纳入一年后，安慰剂组观察到 EDSS 增加（+0.50），10 米步行时间增加（+0.18 秒）； TCV 组的 EDSS（-0.44；p<0.01）和 10 米步行时间（0.84 秒；p<0.005）有所下降。 TCV 组的 17 名患者中有 16 名 (94.1%) 在研究期间保持无复发，而安慰剂组的这一比例为 42.9%（p = 0.01，调整后 p = 0.03）。与安慰剂治疗组相比，TCV 组在研究年内出现任何复发的患者比例减少了 89.6%。 MRI参数没有显着变化。这是第一个 TCV 治疗进展型多发性硬化症的对照、双盲试验。结果证明了该手术的可行性和安全性，并为临床疗效提供了重要的指示。有必要对更大的受试者群体进行进一步的研究。临床试验.gov NCT01448252
T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled. To evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial. Twenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7). T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10–30×106 T-cells, attenuated by irradiation, on days 1, 30, 90 and 180) and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo) were eligible for per-protocol analysis. At one year following the inclusion, an increase in the EDSS (+0.50) and an increase in 10-meter walking time (+0.18 sec), were observed in the placebo group; in the TCV group there was a decrease in the EDSS (−0.44; p<0.01) and in the 10-meter walking time (0.84 sec; p<0.005). Sixteen of the 17 patients (94.1%) in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment). The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly. This is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted. ClinicalTrials.gov NCT01448252
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