A Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Chronic Spinal Cord Injury.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Compared change of Motor Score of the American Spinal Injury Association (ASIA) scale
研究概览
简要总结
This phase II/III clinical trial is designed to evaluate the safety and efficacy of autologous Mesenchymal Stem Cells (MSC) transplanted directly into the injured spinal cord.
详细描述
The Principal investigator has performed a clinical trial using autologous MSCs in patients with cervical spinal cord injury. The results revealed the safety of autologous MSC. This Phase II, III single-center trial is to assess the safety and efficacy of bone marrow-derived mesenchymal stem cell transplantation direct to injured spinal cord site via laminectomy. After recovery from the operation, the subjects receive 4 weeks of physical and occupational therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Aged between 16-65 years
- •Traumatic spinal cord injury at the level of cervical
- •American Spinal Injury Association Impairment Scale B
- •12 months or more post spinal cord injury subject with stable neurological finding after more than 1 month rehabilitation therapy
- •No signs of contracture
- •Good physical condition to go through operation
- •Must be willing and able to participate in study procedures with no mental and verbal problem
- •Able to consent by patients or legal representatives
排除标准
- •Serum SGOT/SGPT > 3 X upper limit of normal or Creatinine > 1.5 X upper limit of normal
- •Major surgical procedure in the past 3 months
- •Penetrating injury
- •Mechanical ventilation
- •Serious pre-existing medical conditions
- •Recently diagnosed infection (Urinary tract infection, Pneumonia etc)
- •Positive skin test for penicillin
- •Positive result for viral markers (human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and Venereal Disease Research Laboratory (VDRL) test)
- •Pregnant women, women of childbearing potential who do not want adequate contraception, breastfeeding females
- •Unwilling to participate in study
- •Patients with psychiatric disorder severe as to make compliance with the treatment unlike, and signing informed consent impossible
- •Drug abuse in the past 1 year
- •Participating in other clinical trials in the past 1 month
- •Inappropriate patients to participate in the study according to the chief investigator
研究组 & 干预措施
cellgram-spine
posterior cervical laminectomy and Mesenchymal stem cells tranplantation. After laminectomy, 1.6X10^7 and 3.2 X10^7 Autologous Mesenchymal stem cells is injected into the intramedullary and intrathecal space respectively
干预措施: cellgram-spine (Drug)
结局指标
主要结局
Compared change of Motor Score of the American Spinal Injury Association (ASIA) scale
时间窗: Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
Compared Baseline and after 6, 12 months of cell treatment, ASIA motor test analyzes the proportion of patients with a motor grade of more than 2 devision, with a motor grade improving from 2 to 3 and a rise of 5 or more in total score. \<American Spinal Injury Association (ASIA) scale\> 0 Total paralysis 1. Palpable or visible contraction 2. Active movement, full Range Of Motion(ROM) with gravity eliminated 3. Active movement, full ROM against gravity 4. Active movement, full ROM against gravity and moderate resistance in a muscle specific position 5. (normal) Active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person 5\* (normal) Active movement, full ROM against gravity and sufficient resistance to be considered normal if identified inhibiting factors (i.e. pain, disuse) were not present NT Not testable
次要结局
- Electrophysiological change (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP)(6 months)
- Sensory score of the American Spinal Injury Association (ASIA) scale(Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month)
- MRI and Diffusion Tensor Imaging of spinal cord(6 months)