Clin Cancer Res:采用间充质干细胞/基质细胞治疗放疗诱导性口干症

2022-05-14 Nebula MedSci原创

间充质干细胞/基质细胞疗法对放疗引起的口干相关症状具有临床意义的疗效

全球每年约有80万人被诊断头颈部癌症,其中70%-80%的病例会采用放疗。对大唾液腺的损伤是头颈部癌症放疗的主要永久副作用,目前仍缺乏适当的治疗措施。

已有研究显示,间充质干细胞/基质细胞 (ASC) 治疗可减少放疗引起的口干症。本研究评估了将自体脂肪组织来源的间充质干细胞/基质细胞注入下颌腺的长期安全性。

这是一项随机、单中心、安慰剂为对照的临床试验,招募了因口咽鳞状细胞癌进行放疗而引起口干症的患者,1:1随机分成两组,在颌下腺分别注射280万 ASC /cm3或安慰剂,并随访至少两年。主要终点是严重不良反应(SAE)的发生率。次要终点包括全唾液流量和口干相关症状。


两组患者的基线特征

共招募了33位患者,其中30位接受了研究干预(两组各15位)。在随访过程中,ASC 组和安慰剂组分别有6位(40%)和5位(33%)患者经历了一次严重不良反应,但经核查,无一与治疗相关


两组患者的主要和次要终点结果

ASC 组和安慰剂组的未刺激全唾液流量分别增加到0.20和0.16 mL/min,两组间的差值为0.05 mL/minute(p=0.051)。ASC 组和安慰剂组患者报告的口干症症状均减少,口干症问卷总分分别下降到35.0分和45.1分(p=0.013)。三个视觉模拟量表口干燥测量表明使用ASC后临床获益。

总而言之,该研究结果表明 ASC 疗法是安全的,对放疗引起的口干相关症状具有临床意义的疗效,值得进一步验证。

原始出处:

Charlotte Duch Lynggaard, et al. Long-term Safety of Treatment with Autologous Mesenchymal Stem Cells in Patients with Radiation-Induced Xerostomia: Primary Results of the MESRIX Phase I/II Randomized Trial. Clin Cancer Res OF1–OF8. https://doi.org/10.1158/1078-0432.CCR-21-4520

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    2022-09-26 wgx306
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