NCT07581197尚未招募1 期
A Phase 1/2 Dose Escalation Study to Evaluate the Safety and Efficacy of SR-02 Pancreatic Endocrine Cell Clusters Implanted in the Omentum of Adults With Type 1 Diabetes (SUGR)
Seraxis0 个研究点目标入组 9 人开始时间: 2026年11月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9
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
- •Adult 18 to 65 years with a clinical history of T1D
- •Diagnosis of T1D at <40 years of age
- •Insulin dependence for ≥5 years at pre-screening
- •Recurrent severe hypoglycemia
- •Willingness to use continuous glucose monitoring
排除标准
- •Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening
- •Weight loss medication(s) within 3 months of Screening
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究者
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