Transplantation of Purified Autologous Bone Marrow- or Leukapheresis-Derived CD34+ and CD133+ for Patients With Spinal Cord Injuries: A Long-Term Comparative Evaluation of Safety and Efficacy Study.
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association)
研究概览
简要总结
This is a double-armed, Phase I/II trial aims to compare bone marrow and leukapheresis as sources for purified, autologous CD34+ and CD133+ stem cells (SCs), to be utilized in treatment of patients with chronic complete spinal cord injuries (SCI). The study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells into the injured spinal cords of patients.
详细描述
Spinal cord injury (SCI) leads to apoptosis of oligodendrocytes at the injury site resulting in demyelination and neuronal degeneration. This degeneration causes severe functional sensory and motor mutilations that remain an immense challenge to physicians and in which stem cell (SC) transplantation represents a viable alternative. This study is a phase I/II trial aimed at describing a method for treating patients with chronic complete spinal cord injuries (SCI) by utilizing autologous, purified CD34+ and CD133+ stem cells (SCs). The study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells in treated patients during a 5-year follow-up period.
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
- None
入排标准
- 年龄范围
- 5 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from chronic spinal cord injury
- •Age of injury ranging from 6-60 months prior to enrollment in this study.
- •Ability and willingness to regularly visit Jordan Orthopedic and Spinal Center for post operation follow up.
- •Traumatic Injury of spinal cord with complete or partial damage confirmed by MRI.
排除标准
- •Injuries less than 6 months old or more than 60 months old
- •Non-traumatic injuries (SCI due to inflammation, autoimmune diseases)
- •Patients less than 5 or older than 50 years
- •Patients suffering from other conditions, including chronic neurological diseases, diabetes mellitus, cardiac/kidney/liver disorders, previous strokes, and previous surgeries unrelated to spinal cord injury.
结局指标
主要结局
Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association)
时间窗: 60 months
次要结局
- Improvement in quality of life using a questionnaire(6 months)
- Improvement in personal independence and productivity using questionnaire(6 months)
- Functional improvement in impotence and previous sexual erection status (male patients) using a questionnaire(6 months)
- Improvement in urine and stool incontinence using a questionnaire(6 months)