NCT06731218招募中1 期
A Single-Center, Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 1 Diabetes Mellitus
Hangzhou Reprogenix Bioscience, Inc1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年2月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety as assessed by number of subjects with adverse events
研究概览
简要总结
This Phase I clinical trial is a single-center, single-arm, open-label study aimed at evaluating the safety and therapeutic efficacy of RGB-5088 islet cell transplantation in patients with Type 1 Diabetes Mellitus.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-60 years old (including 18 and 60 years old), male and female;
- •Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney);
- •Stimulated C-peptide < 0.3 ng/mL;
- •The patient had at least one severe hypoglycemia within 12 months before being included in the project
排除标准
- •Type 2 diabetes patients;
- •Untreated proliferative diabetes retinopathy;
- •Serious heart disease;
- •Serious gastrointestinal dysfunction ；
- •Serious psychological diseases；
- •Any history of malignancy;
- •Have a history of tobacco, alcohol and drug abuse;
- •For female subjects: pregnancy test positive, lactation or unwilling to use effective contraceptive measures during the study period, male patients: intent to procreate or unwilling to use effective contraceptive measures during the study period.
研究组 & 干预措施
RGB-5088
Experimental
Transplantation under the anterior rectus sheath
干预措施: RGB-5088 (Biological)
结局指标
主要结局
Safety as assessed by number of subjects with adverse events
时间窗: From RGB-5088 transplantation to one year later
Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events
时间窗: From 90 days to 365 days after RGB-5088 transplantation
次要结局
- Safety as assessed by number of subjects with adverse events(From RGB-5088 transplantation to end of study (up to 5 years))
- Proportion of subjects who are insulin independent(From 90 days to end of study (up to 5 years))
- Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events(From 90 days to end of study (up to 5 years))
研究者
研究点 (1)
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