预期双盲随机研究,对单剂量骨髓衍生中细胞与安慰剂进行单剂量骨髓衍生中细胞对抗类固醇耐受性急性移植对宿主疾病的研究
Olle Ringdén1, Guido Moll2,3,4, Britt Gustafsson1
1Translational Cell Therapy Research, Division of Pediatric, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institute, Stockholm, Sweden.
概括
单次输注骨髓中介质 stromal 细胞 (BM-MSCs) 并没有显著改善严重急性移植对宿主疾病 (GVHD) 患者的结果. 在BM-MSC和安慰剂组之间,反应率和生存率相似,这表明疗效有限.
科学领域:
- 血液学 血液学 血液学
- 免疫学 免疫学 免疫学
- 细胞疗法细胞疗法
背景情况:
- 严重的急性移植对宿主疾病 (GVHD) 是异性干细胞移植后的一个主要并发症.
- 介质细胞/干细胞 (MSC) 由于其免疫调节特性,已被研究为GVHD的潜在治疗方法.
研究的目的:
- 为了评估第三方骨髓 (BM) -MSCs单次输注在患有类固醇耐药急性GVHD的患者中的疗效.
主要方法:
- 进行了一项随机对照试验,其中23名患者被诊断患有II-IV级耐固醇急性GVHD.
- 患者接受了 BM-MSCs (2 × 10 ^ 6 / kg) 或安慰剂的一次输注.
- 评估了包括响应率,移植相关死亡率 (TRM) 和生存率在内的结果.
主要成果:
- 在第28天,BM-MSC组的完全响应率为50%,安慰剂组为27% (p=0.68).
- 100天的TRM为BM-MSCs的17%,与安慰剂的27%.
- 五年生存率相似:BM-MSCs的42%和安慰剂的45% (p=0.87).
结论:
- 在这项小型试验中,单剂量BM-MSCs在治疗类固醇耐药急性GVHD方面没有显著的疗效.
- 用更大的队列或不同的剂量策略进行进一步的研究可能是合理的.
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