The Efficacy and Safety of Intra-arterial Administration of REX-001 to Treat Ischemic Ulcers in Subjects With Critical Limb Ischemia (CLI) Rutherford Category 5 and Diabetes Mellitus: A Pivotal, Placebo-controlled, Double-blind, Parallel-group, Adaptive Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Ixaka Ltd
- 入组人数
- 49
- 试验地点
- 15
- 主要终点
- Complete healing of all ischemic ulcers on the index leg.
研究概览
简要总结
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5. Minimisation will be used to assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of REX-001 or matching placebo into the index limb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 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
REX-001
REX-001 is a cell suspension of autologous bone marrow mononuclear cells (BM-MNCs) composed of several mature cell types.
干预措施: REX-001 (Drug)
Placebo
The final formulation of the placebo will be a diluted suspension of red blood cells.
干预措施: Placebo (Drug)
结局指标
主要结局
Complete healing of all ischemic ulcers on the index leg.
时间窗: The primary endpoint for this trial will be assessed at 12 months.
Change in Rutherford classification from CLI Category 5 to Category 4 or lower 12 months. after administration of REX-001 or placebo.
次要结局
未报告次要终点