EUCTR2018-003856-19-DK进行中（未招募）1 期
A Phase I Open Label Study Evaluating the Safety and Feasibility of Allogeneic Mesenchymal stem cells for radiation-induced hyposalivation and xerostomia in previous oropharyngeal patients
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology. Rigshospitalet, University Hospital of Cph, DK0 个研究点目标入组 10 人开始时间: 2018年10月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Informed consent
- •Previous radiotherapy for oropharyngeal OPSCC cancer stage I-II
- •2 years of follow-up without recurrence
- •Clinically hyposalivation:unstimalted salivary flow < 0.2 ml/min and above 0.05 ml/min
- •Grade 1-3 Xerostomia evaluated by UKU side effect rating scale
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Any cancer in the previous 2 years ( not including basocellular carcinoma and OPSCC)
- •Xerogenic medications
- •Any current or previous otjer diseases in the salivary glands ( e.g Sjögrens syndrome, Sialolithiasis)
- •Pregancy or planned pregnancy within the next 2 years
- •Breastfeeding
- •Any other disease/condition juged by the investigator to be grounds for exclusion
研究者
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