在患有多发性硬化症的患者中,输静脉移植骨髓衍生的中细胞,一期I/IIa,双盲,随机对照研究
Seyed Massood Nabavi1, Shahedeh Karimi1, Leila Arab1
1Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, Tehran, Iran.
Multiple sclerosis and related disorders
|July 29, 2023
概括
对多发性硬化症 (MS) 进行的介质干细胞疗法是安全的,但在这个小型试验中没有显示出显著的疗效. 需要进一步的研究和更大的研究来确认对MS患者的潜在益处.
科学领域:
- 神经免疫学 神经免疫学
- 再生医学是一种再生医学.
- 临床试验 临床试验
背景情况:
- 多发性硬化症 (MS) 是一种神经退行性疾病,导致残疾,目前的治疗方法提供有限的益处.
- 介酶体 stromal 细胞 (MSCs) 在神经退行性条件下显示出免疫调节和再生的前景.
- 需要新的治疗策略来解决多发性硬化症的进展,并促进神经修复.
研究的目的:
- 评估MS患者自身骨髓衍生MSC移植的安全性和潜在疗效.
- 评估MSC治疗对MS患者临床结果,生物标志物和成像发现的影响.
主要方法:
- 进行了一项随机对照的临床试验,涉及21名多发性硬化患者.
- 患者接受了自主骨髓衍生的MSC或安慰剂,具有交叉设计.
- 随访包括临床评估,实验室测试和18个月的MRI成像.
主要成果:
- 在两组中都没有报告MSC移植后发生的严重不良事件.
- 两组之间没有观察到复发率,残疾分数 (EDSS),认知功能或MRI发现的显著差异.
- 脑脊液中的生物标志物分析也显示,干预后没有显著变化.
结论:
- 自主骨髓衍生的MSC的系统移植对于MS患者来说是安全的和可行的.
- 目前的研究没有证明显著的治疗疗效,这表明需要进行更大规模的试验.
- 未来的研究应该探索不同的MSC类型,施用途径和延长后续期,以更好地评估疗效.
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