室内异构介质干细胞:一种针对急性非动脉炎视神经病变的非随机二期临床试验
Jose C Pastor1,2,3,4, Salvador Pastor-Idoate5,6,7, Marina López-Paniagua1,2,3,8
1Instituto de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Campus Miguel Delibes, Pº de Belén nº 17, 47011, Valladolid, Spain.
Stem cell research & therapy
|September 22, 2023
概括
内注射全基性骨髓衍生性介质干细胞 (BM-MSCs) 显示出治疗急性非动脉炎性缺血性视觉神经病变 (NA-AION) 的潜力. 虽然通常是安全的,但需要进一步的大规模试验来确认有效性.
科学领域:
- 眼科医生 眼科 眼科
- 再生医学是一种再生医学.
- 神经科学是一个神经科学.
背景情况:
- 急性非动脉炎性缺血性视神经病变 (NA-AION) 缺乏经过验证的有效治疗方法.
- 全基性骨髓衍生中酶干细胞 (BM-MSCs) 已显示出潜在的神经保护作用.
研究的目的:
- 在急性NA-AION患者中评估肠内BM-MSC的安全性和潜在疗效.
- 报告研究这一新型治疗方法的临床试验的结果.
主要方法:
- 预期的,非随机的,第二阶段临床试验 (NCT03173638).
- 包括5名急性单边NA-AION患者在症状出现后2周内.
- 同源性BM-MSCs (MSV®) 的静脉内注射,随访一年.
主要成果:
- 内BM-MSCs通常耐受良好,没有显著的眼内炎症或压力变化.
- 在5名患者中,有4名观察到视觉改善,在3名患者中,视觉唤起的潜能增加了P100幅度.
- 一名患者患上了视网膜膜;另一个患者在经过过时的逆转凝聚物后患上了亚囊性白内障.
结论:
- 在急性NA-AION治疗中,内异构BM-MSC似乎是安全的.
- 需要对更大规模的随机多中心试验进行进一步的研究,以确认安全性和治疗疗效.
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