A Pilot Study Treating Radiation-Induced Xerostomia Using Allogeneic Mesenchymal Stromal Stem Cells
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events of Allogeneic MSC Treatment for Radiation-Induced Xerostomia
研究概览
简要总结
This pilot interventional study evaluates the safety and preliminary efficacy of treatment with allogeneic mesenchymal stromal stem cells (MSCs) derived from umbilical cord tissue in patients with radiation-induced xerostomia after radiotherapy for head and neck cancer. Xerostomia is a frequent late adverse effect of radiotherapy and can significantly impair oral function and quality of life.
Participants receive a single administration of allogeneic MSCs as the study intervention and are followed for clinical outcomes. The study evaluates safety, salivary gland function, subjective xerostomia symptoms, and imaging-based changes in salivary gland tissue.
The results of this pilot study may support the development of regenerative treatment strategies for radiation-induced salivary gland damage.
详细描述
This is a prospective pilot interventional clinical study designed to assess the safety and preliminary efficacy of treatment of radiation-induced xerostomia using allogeneic mesenchymal stromal stem cells (MSCs) derived from umbilical cord tissue. Radiation-induced xerostomia is a common late complication in patients treated with radiotherapy for head and neck cancer and is associated with reduced salivary flow, impaired oral health, swallowing difficulties, and decreased quality of life.
Allogeneic MSCs are characterized by strong immunomodulatory properties and regenerative potential. In this study, MSCs obtained from umbilical cord tissue are administered as a therapeutic intervention to evaluate their potential to improve salivary gland function and reduce symptoms of xerostomia.
The primary objective of the study is to assess the safety of MSC administration, with follow-up monitoring for adverse events during a four-month period after the intervention.
Secondary objectives include evaluation of preliminary efficacy of MSC therapy by assessing:
subjective xerostomia symptoms and patient-reported outcomes,
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •History of radiotherapy for head and neck cancer
- •Presence of radiation-induced xerostomia
- •Completed oncological treatment
- •Ability to understand the study procedures and provide written informed consent
排除标准
- •Active malignant disease requiring ongoing oncological treatment
- •Acute infection or inflammation in the oral cavity or salivary glands
- •Severe systemic disease or condition that could influence study results
- •Contraindication to the planned intervention (MSC administration)
- •Pregnancy or breastfeeding
- •Any condition that, in the investigator's opinion, would interfere with participation or evaluation of outcomes
研究组 & 干预措施
Allogeneic MSC Treatment for Radiation-Induced Xerostomia
Participants with radiation-induced xerostomia following radiotherapy for head and neck cancer receive a single administration of allogeneic mesenchymal stromal cells (MSC) derived from umbilical cord tissue. The intervention is performed according to the study protocol, and participants are prospectively followed to assess safety and preliminary efficacy, including salivary gland function, salivary quality, imaging findings, and patient-reported outcomes related to xerostomia.
干预措施: Allogeneic Mesenchymal Stromal Cells (MSC) (Biological)
结局指标
主要结局
Incidence of treatment-emergent adverse events of Allogeneic MSC Treatment for Radiation-Induced Xerostomia
时间窗: From intervention through 4 months after the intervention
Safety is assessed by the incidence, type, and severity of adverse events and serious adverse events following administration of allogeneic umbilical cord-derived mesenchymal stromal cells (MSC) in participants with radiation-induced xerostomia.
次要结局
未报告次要终点