A Phase II Multicenter, Randomized-Controlled Study to Evaluate the Safety and Efficacy of Autologous Incubated Macrophages for the Treatment of Patients With Complete Spinal Cord Injuries
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 61
- 试验地点
- 13
- 主要终点
- Improvement of ASIA grade
研究概览
简要总结
Autologous Incubated Macrophages (ProCord) is being developed as a therapy for acute, complete spinal cord injury (SCI). The therapy is intended to reverse the loss of motor and sensory function.
Following non-CNS tissue injury, macrophages quickly arrive on the scene, where they clean up cell debris, secrete different molecules thus promoting a controlled inflammatory reaction that forms the first phase of the wound healing process. While this process occurs in most tissues, including peripheral nerves, it does not occur in the CNS, where macrophages and other immune cells are relatively rare, and their activities curtailed by a biochemical mechanism known as "immune privilege."
In animal studies, it appears that incubated macrophages circumvent the immune privilege, thus supporting the regrowth of axons through the injury site and enabling the recovery of neurological function. The concept derives from the pioneering research of Prof. Michal Schwartz at the Weizmann Institute of Science.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic SCI during last 14 days
- •Age 16 to 65 years
- •Complete spinal cord injury (ASIA A)
- •Neurological level : C5 to T11
- •MRI showing lesion
排除标准
- •Women who are pregnant or breastfeeding
- •Coma or other severe injury or disease
- •Penetrating injury
- •Ongoing mechanical ventilation
- •Unsuitable based on MRI or other factor
结局指标
主要结局
Improvement of ASIA grade
次要结局
- Sensory scores
- Motor scores
- Bladder and bowel function
