Salivary Gland Autotransplantation of Marrow Mesenchymal Stromal Cells for Treatment of Radiation-induced Xerostomia - FDA IND (Investigational New Drug) Enabling Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of Participant's whose Marrow-Derived MSCs Can be Expanded in vitro to > 50 million cells within two weeks
研究概览
简要总结
Xerostomia, or dry mouth, is a common side effect of head neck radiation. Current treatment options for radiation-induced xerostomia are generally supportive in nature. Most of these supportive interventions do not reverse xerostomia and are palliative in intent.
The investigators propose that autotransplantation of marrow-derived mesenchymal stromal cells (MSCs) in salivary glands post-RT or post-chemoradiation therapy (CRT) may provide an innovative remedy to treat xerostomia and restore quality of life.
Participants can expect to be on study for up to 6 months.
详细描述
This feasibility study will analyze the salivary composition, salivary viscoelasticity, salivary gland US, and QoL surveys of participants without head and neck cancer (HNC) to determine standard values. The investigators will then compare this to the salivary composition and viscoelasticity of participants with treated HNC.
Additionally, the investigators will examine the paracrine factors of marrow MSCs in order to prove a hypothesis that paracine factors constitutively expressed by marrow MSCs [Wnts, fibroblast growth factors (FGFs), GDNF and others] will directly influence the biology of dormant salivary gland stem cells following intraglandular transplantation and allow for functional recovery following RT.
Primary Objective
- To determine the feasibility of in vitro expansion of marrow-derived MSCs from HNC patients to >50 million cells.
Secondary Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥2 years from completion of chemoradiation therapy or radiation therapy (N=6) with subjective complaint of xerostomia or with no diagnosis of HNC (N=5)
- •Karnofsky ≥ 60, participant eligible for bone marrow aspirate with wakeful anesthesia
- •Not pregnant
- •Willing and able to give informed consent
- •non-HNC participants only need to meet the following applicable inclusion criteria
- •No history of radiation to the salivary glands
- •Willing and able to give informed consent
排除标准
- •Salivary gland disease (e.g., sialolithiasis)
结局指标
主要结局
Number of Participant's whose Marrow-Derived MSCs Can be Expanded in vitro to > 50 million cells within two weeks
时间窗: Up to 1 day to collect, subsequently cultured in vitro for up to 2 weeks
The feasibility of in vitro expansion of MSCs derived from marrow aspirates collected from participants will be determined by if they can be culture expanded for up to two weeks to generate \>50 million MSCs per donor. Feasibility will reported as the number of participants whose marrow-derived MSCs can be expanded in vitro to \> 50 million cells within two weeks.
次要结局
- Change in participant QoL: XeQOL(baseline and up to 6 months)
- Change in participant Salivary Function: Unstimulated(baseline and up to 6 months)
- Change in participant QoL: VAS(baseline and up to 6 months)
- Change in participant Salivary Gland Size(baseline and up to 6 months)
- Change in participant QoL: MDADI(baseline and up to 6 months)
- Change in participant Salivary Function: Stimulated(baseline and up to 6 months)