NCT04990427已完成1 期
A Phase 1 Open-Label, Proof-of-Concept Study to Evaluate the Safety and Efficacy of CLBS201 Autologous Peripheral Blood-Derived CD34+ Cells in Subjects with Chronic Kidney Disease and Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Serious Adverse Events
研究概览
简要总结
CLBS201 will evaluate the safety, tolerability, and therapeutic effect in subjects with CKD and T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years, inclusive
- •Documented diagnosis of type 2 diabetes
- •eGFR of 30 to <45 mL/min/1.73m at the screening visit.
- •UACR 300 mg/g to ≤ 5000 mg/g
排除标准
- •Hemoglobin < 10 g/dL
- •Hemoglobin A1c ≥8% at the time of screening
- •Acute kidney injury within 6 months prior to screening
研究组 & 干预措施
CLBS201
Experimental
CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation.
干预措施: CLBS201 (Drug)
结局指标
主要结局
Serious Adverse Events
时间窗: 6 Months
Proportion of patients with a treatment-emergent serious adverse event
次要结局
- Estimated Glomerular Filtration Rate (eGFR)(6 Months)
- UACR & UPCR(6 Months)
研究者
研究点 (1)
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