A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events
研究概览
简要总结
The goal of this clinical research study is to evaluate the safety and tolerability of injecting certain cells that you produce in your bone marrow called mesenchymal stem cells (MSCs) into your salivary glands.
Participants will have head and neck cancer that was treated with radiation therapy, and in this study will:
- Undergo a collection of bone marrow using a needle;
- Donate saliva;
- Undergo a salivary gland ultrasound; and,
- Complete questionnaires that ask about dry mouth
Participants can expect to be in this study for up to 30 months.
There is no expanded access program available per this protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of histological diagnosis of head and neck cancer (HNC) that was treated with radiation therapy and currently clinically or radiologically no evidence of disease (NED)
- •Xerostomia, defined as patient reported salivary function (pre-treatment) ≤ 80% of healthy (pre-radiation)
- •≥ 18 years of age, ≤ 90 years of age.
- •Patients ≥ 2 years from completion of radiation therapy for HNC
- •Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia
- •Willing and able to give informed consent
- •Radiographically confirmed submandibular gland(s)
排除标准
- •Salivary gland disease (i.e., sialolithiasis)
研究组 & 干预措施
Mesenchymal Stem Cell (MSC) injection
干预措施: MSC (Drug)
结局指标
主要结局
Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events
时间窗: Up to 1 month post-injection
Incidence of pre-specified adverse events
Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D)
时间窗: Up to 1 month post-injection
RP2D (also called the maximum tolerated dose) of MSCs determined by the proportion of subjects experiencing dose limiting toxicity (DLT)
Safety and Tolerability: Number of subjects with pain >5 on a 0-10 point scale
时间窗: 1 month post-injection
Incidence of pain assessed as greater than 5 on standard 0-10 point pain scale (0=not at all to 10=worst pain imaginable)
Safety and Tolerability: Number of Serious Adverse Events
时间窗: Up to 1 month post-injection
Incidence of any serious adverse event
次要结局
- Shear wave velocity with acoustic radiation force impulse(3, 6, and 12 months post-injection)
- Change in salivary production(Baseline to 24 months post-injection)
- Change in Quality of Life(Baseline to 24 months post-injection)