A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Complicated Post-surgical Fistulas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (The Gore Fistula Plug) in a Phase I study using a single dose of 20 million cells. 15 adult patients (age 18 and greater) with persistent symptomatic post-surgical gastrointestinal leaks despite current standard radiologic and endoscopic therapies will be enrolled. The subjects will be subsequently followed for fistula response and closure for 18 months. This is an autologous product derived from the patient and used only for the same patient.
详细描述
Visit 1: Patients will be evaluated for eligibility (inclusion/exclusion checklist) and written, informed consent will be obtained. Patients will undergo general exam with vital signs. Patients will be scheduled for a fat biopsy to collect the tissue needed to grow MSC. In the event there is no cell growth from the tissue obtained from the first biopsy, one further attempt will made from a second tissue sample from this patient. However, if the second attempt fails to grow cells, no further attempts will be made, and the subject will not continue in the study.
Visit 2 (Week 0; Day 0): Patients will undergo an interventional endoscopy, the fistula tract will be assessed and the stem cell coated will be placed endoscopically.
Study visit will be as follows:
Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8; Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (week 52; Month 12) Visit 10 (Week 78; Month 18)
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MSC Fistula plug: Single Treatment Group
All patients received treatment of a stem cell coated fistula plug.
干预措施: MSC Fistula Plug (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 2-18 months
Data collection will include: worsening of the fistula, abnormal laboratory values, or significant abnormalities in physical examination. The Outcome Measure will be the number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
次要结局
- Incidence of Fistula Closure(2-18 months)