跳至主要内容
临床试验/NCT00073853
NCT00073853暂停2 期

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

Proneuron Biotechnologies13 个研究点 分布在 2 个国家目标入组 61 人开始时间: 2003年9月1日最近更新:
适应症

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

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

研究者

发起方
Proneuron Biotechnologies
申办方类型
Industry

研究点 (13)

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