NCT06408311进行中（未招募）1 期
A Safety and Tolerability Study of ENC=201-CED in Participants With Type 1 Diabetes Receiving Islet Infusion
Encellin2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of ENC-201-CED in a subcutaneous space in patients with Type I diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates must satisfy site's eligibility for standard of care islet infusion.
排除标准
- •Candidates are excluded based on the site's criteria for standard of care islet infusion.
研究组 & 干预措施
ENC-201-CED hPI
Experimental
干预措施: ENC-201-CED hPI (Combination Product)
结局指标
主要结局
Safety
时间窗: Day 1 through Day 134
Rate of device-related Adverse Events (AE)
次要结局
- Containment(post Day 120)
- Engraftment(post Day120)
研究者
研究点 (2)
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