A Phase I Open Label Study Evaluating the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia in Previous Oropharynx Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Safety: Number of patients with serious adverse events
研究概览
简要总结
An investigator-initiated, non-randomized, open label study to investigate the safety, feasibility and tolerability of intraglandular injection of allogeneic mesenchymal stem/stromal cells (MSCs) into the submandibular and parotid glands of the patients with radiation-induced hyposalivation and xerostomia after radiation for a oropharyngeal squamous cell carcinoma
详细描述
Patients with previous oropharyngeal cancer and radiation-induced hyposalivation and xerostomia (dry mouth syndrome) will receive intraglandular injections of allogeneic adipose-derived MSCs into the submandibular and parotid glands. The trial will be Good Clinical Practice (GCP) Monitored. From healthy donors, MSCs will be produced at a Good Manufacturing Practice (GMP) Facility.
The patients will be followed for four months for safety, tolerability, and efficacy registration. Changes in quality of life, unstimulated, and stimulated whole saliva flow rate, salivary gland function will be assessed. Immune response towards receiving allogeneic MSCs will be evaluated in plasma and saliva. Changes in the composition and quality of the whole saliva will be investigated.
Saliva from the participants will altså be compared to saliva from ten healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-75 years
- •Previous radiotherapy +/- chemotherapy for OPSCC stage I- II (UICC-8, 2017)
- •2 years' follow-up without recurrence
- •Clinically reduced salivation and hyposalivation, evaluated by a screening
- •Unstimulated salivary flow rate between 0.2mL/min and 0.05mL/min
- •Grade 2-3 xerostomia (CTCAEv5.0)
- •WHO Performance status (PS) 0-1
- •Informed consent
排除标准
- •Any cancer in the previous 4 years (not including OPSCC and basocellular carcinomas)
- •Xerogenic medications
- •Penicillin or Streptomycin allergy
- •Any other diseases of the salivary glands, e.g. Sjögren's syndrome or sialolithiasis
- •Previous parotid or submandibular gland surgery
- •Previous treatment with any type of stem cells
- •Breastfeeding, Pregnancy or planned pregnancy within the next 2 years
- •Smoking within the previous 6 months.
- •Alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (Danish National board health alcohol guidelines3)
- •Any other disease/condition judged by the investigator to be grounds for exclusion
结局指标
主要结局
Safety: Number of patients with serious adverse events
时间窗: 4 months
Registration of number of patients with serious adverse events in a 4 months follow-up period
次要结局
- Efficacy: Change in Stimulated Whole Salivary flow rate(4 months)
- Efficacy: Change in quality of life(4 months)
- Efficacy: Change in Saliva composition(4 months)
- Efficacy: Change in Saliva Proteomics(4 months)
- Efficacy: Change in RNA in Saliva(4 months)
- Immune reponse(4 months)
- Efficacy: Change in Unstimulated Whole Salivary flow rate(4 months)
- Immune reponse :Development of donor specific antibodies(4 months)
- Efficacy: Salivary gland function(4 months)
研究者
Charlotte Lynggaard
Principal Investigator
Rigshospitalet, Denmark