NCT07464119尚未招募不适用
A Single-Arm, Open-Label Clinical Study of iPSC-Derived Islet Cells for the Treatment of Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a single-arm, open-label clinical trial designed to assess the safety and therapeutic efficacy of iPSC-derived islet cell infusion in patients with 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 years or older, of any sex.
- •Duration of diabetes > 5 years.
- •Body mass index (BMI) 18-35 kg/m².
- •Receiving insulin therapy.
排除标准
- •Presence of HIV infection , or active acute or chronic hepatitis infection (HBV or HCV), or Treponema pallidum infection.
- •Active pulmonary tuberculosis or patients undergoing treatment for suspected tuberculosis.
- •Uncontrolled systemic fungal, bacterial, viral, or other infections .
- •Presence of severe diabetic complications.
- •Presence of severe organic lesions in vital organs such as the heart, lungs, or brain.
- •History of malignant tumors.
研究组 & 干预措施
iPSC-derived islet cell
Experimental
干预措施: iPSC-derived islet cell (Biological)
结局指标
主要结局
Adverse events
时间窗: From enrollment to month 6
次要结局
- Change from baseline in glycosylated hemoglobin (HbA1c)(From enrollment to month 6)
- Change from baseline in exogenous insulin dosage(From enrollment to month 6)
研究者
Zhang Junqing
Chief Physician
Peking University First Hospital
研究点 (1)
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