A Phase 1/2 Adaptive Dose Study to Evaluate the Safety and Efficacy of SR-02 Pancreatic Endocrine Cell Clusters Implanted in the Omentum of Adults With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- To investigate the safety and tolerability based on the percentage and relatedness of all treatment emergent adverse events and serious adverse events (TEAEs and SAEs)
研究概览
简要总结
This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.
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 65 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
SR-02 Allogeneic pancreatic endocrine cell clusters
干预措施: Allogeneic Pancreatic Endocrine Cell Clusters (Biological)
结局指标
主要结局
To investigate the safety and tolerability based on the percentage and relatedness of all treatment emergent adverse events and serious adverse events (TEAEs and SAEs)
时间窗: day 35 through day 365
The effect on endogenous insulin secretion as assessed by 90-minute MMTT-stimulated C-peptide >0.5 ng/ml (>0.17 nmol/L)
时间窗: 90 day intervals through day 365
次要结局
未报告次要终点