Follow-up Study of Safety and Efficacy in Subjects Who Participated in the Study of Intraglandular Mesenchymal Stem Cells in Patients With Radiation-induced Hyposalivation and Xerostomia (MESRIX)
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Relapse of oropharyngeal cancer
研究概览
简要总结
A prospective study for long-term follow-up (LTFU) to evaluate safety and efficacy in subjects who participated in the Phase 1/2 randomized placebo-controlled trial MESRIX.
详细描述
This is a LTFU study to assess the long-term and late effects of treatment with MSCs or placebo given ultrasound-guided into the submandibular glands in subjects participating in the MESRIX trial. Study participants from the MESRIX trial will be invited for a clinical visit. The visit will include medical history, an ENT examination; measurements of the saliva production by sialometry, a Magnetic resonance imaging scan (MRI) and obtaining data on the patient-reported outcome with Xerostomia Questionnaire (XQ) and Visual-Analogue-Symptomatic scale (VAS). Subjects, who are not able or willing to attend a clinical visit, will be encouraged to fill out the Questionnaires online or on paper. If a study participant has deceased, information of the cause of death will be investigated in The Danish Register of Causes of Death
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Assessment of safety and treatment efficacy in subjects who were enrolled in the MESRIX Phase I/II clinical trial
- •Subjects who were treated with either autologous mesenchymal stem cells or placebo
- •Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the trial
排除标准
- •Subjects who were not enrolled in the MESRIX trial
结局指标
主要结局
Relapse of oropharyngeal cancer
时间窗: 5 years from randomization
Number of participants with relapse will be reported
Safety: Serious Adverse Events (SAEs) and new chronic diseases
时间窗: 5 years from randomization
SAEs according to the ICH-GCP definition and new chronic diseases. For patients not attending the planned hospital visit consider searching The National Patient Register will be searched for registered SAEs. Number of patients
New malignancies
时间窗: 5 years from randomization
Number of subjects who have new malignancies will be reported
Zoonotic Diseases
时间窗: 5 years from randomization
Number of subjects diagnosed Zoonotic Diseases will be reported
Overall survival
时间窗: 5 years from randomization
Overall survival is defined as the time from the intraglandular dose of the investigational product (MSCs or placebo) to the date of death or the date the subject is last known to be alive
次要结局
- Patient-reported outcome measures-Health-related quality of life (HRQoL(5 years from randomization)
研究者
Charlotte Lynggaard
Principal Investigator
Rigshospitalet, Denmark