NCT02567240已完成1 期
A Novel Approach to Harvest Islets for Autologous Islet Transplantation
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Area under the curve during mixed meal tolerance test
研究概览
简要总结
The goal of this study is to determine whether harvesting islets using carbon monoxide (CO)-saturated mediums can protect islet cell from death after autologous islet transplantation in patients with chronic pancreatitis.
详细描述
Investigators plan to harvest human islets using carbon monoxide-saturated mediums. Survival and function of transplanted islets will be compared with islets harvested using regular mediums.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pancreatitis patient selected for total pancreatectomy and islet autotransplantation.
- •Age between 18-69.
排除标准
- •Had prior pancreatic surgeries.
- •Note: The study was initially designed only to enroll diabetes free patients. To increase enrollment, we extended the inclusion criteria by allowing patients who are pre-diabetic to participate the study. This revision was approved by the MUSC IRB on 11/10/2015.
研究组 & 干预措施
Carbon monoxide-bubbled mediums
Experimental
Islets will be harvested with Carbon monoxide-saturated mediums
干预措施: Carbon monoxide-bubbled mediums (Other)
Normal mediums
No Intervention
Islets will be harvested with regular mediums
结局指标
主要结局
Area under the curve during mixed meal tolerance test
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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