在COVID后综合征中使用REGENECYTE带血细胞治疗:IIa期随机,安慰剂对照试验
Yen-Wen Huang1, Ying-Chieh Chen1, Ernest Yin Lun Lau1
1StemCyte Taiwan, Co.,Ltd., New Taipei City, Taiwan.
EClinicalMedicine
|February 2, 2026
概括
后COVID疲劳综合征影响全球许多人. 一种带血疗法REGENECYTE在疲劳和生活质量方面显著而持久地改善,在IIa期试验中显示出良好的安全性.
科学领域:
- 再生医学是一种再生医学.
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 后COVID综合征带来了重大的全球健康和经济挑战.
- 疲劳是后COVID综合征的主要衰弱症状,缺乏向治疗.
- 这项研究研究了REGENECYTE,一种全方位的造血原生细胞 (HPC) 疗法,用于COVID后的疲劳.
研究的目的:
- 评估在COVID后综合征患者中重复注射REGENECYTE的安全性和耐受性.
- 评估REGENECYTE在改善疲劳和其他与后COVID综合征相关的症状方面的疗效.
- 探索带血衍生HPC疗法对COVID后疲劳的治疗潜力.
主要方法:
- 一个随机的,单盲,安慰剂控制的IIa期试验,涉及30名患有持续后COVID症状的成年人.
- 参与者在6周内接受了多次静脉注射REGENECYTE或安慰剂,并进行了20周的随访.
- 主要终点:安全性 (NCI CTCAE v5.0). 这是一个主要的终点. 其次终点:疲劳 (CFQ-11). 探索性终点:脆弱性,生活质量,认知.
主要成果:
- 在10%的患者中,REGENECYTE的耐受性很好,只有10%的患者出现了轻微的治疗不良事件.
- 与安慰剂相比,观察到疲劳症状 (CFQ-11分数) 的显著和持续改善 (p < 0.01).
- 人们注意到生活质量的改善,特别是在日常活动和精神健康方面,脆弱性或认知能力没有显著变化.
结论:
- 当从无匹配的带血献血者进行重复输注时,REGENECYTE是一种安全且耐受良好的COVID后综合征治疗方法.
- 该疗法可提供有意义和持久的减轻疲劳,解决后COVID综合征的关键负担.
- 这些发现支持进一步临床开发以带血为基础的治疗方法,用于COVID后的疲劳和其他相关疾病.
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