Safety and Effect of Lithium, Umbilical Cord Blood Cells and the Combination in the Treatment of Acute and Sub-acute Spinal Cord Injury : a Randomized, Double-Blinded Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change from Baseline in AIS Motor and sensory scores and ASIA Impairment Scales in 48 weeks
研究概览
简要总结
The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical cord blood mononuclear cell transplant, and the combination in the treatment of acute and subacute spinal cord injury
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •either gender and 18-65 years old;
- •acute or subacute traumatic spinal cord injury (defined as SCI resulting from an exteneral non-penetrating cause that occurred within 4 weeks);
- •neurological status of ASIA A;
- •neurological level between C5-T11;
- •MRI shows injury site is within 3 vertebral level and necrotic focus, if exist, is less than 1/3 of the spinal cord diameter;
- •professional judgment determinate that subjects need a spinal decompression surgery;
- •subjects able to complete neurological examination;
- •subjects have voluntarily signed and dated an informed consent form.
排除标准
- •penetration SCI such as gun-shoot, knife-cutting or SCI caused by non-traumatic conditions;
- •spinal cord lesion exceeds three segments or necrotic focus with diameter larger than 1/3 of the spinal cord;
- •severe complications;
- •significant medical diseases or infection;
- •pregnant or lactating woman, or female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study;
- •unavailability of suitable umbilical cord blood cells;
- •contraindication of lithium carbonate and/or spinal decompression surgery
- •subject is currently participating in another study or has been taking any investigational drug within the last 4 weeks prior to screening;
- •investigator suggests that the subject would not be suitable to participate this study
研究组 & 干预措施
Group D - Combination Therapy
Conventional treatment, cell transplant and 6-weeks course of lithium carbonate
干预措施: Conventional Treatment (Procedure)
Group C - Cord blood cell
Conventional treatment, cord blood cell transplant and placebo
干预措施: Conventional Treatment (Procedure)
Group C - Cord blood cell
Conventional treatment, cord blood cell transplant and placebo
干预措施: Cord Blood Cell (Biological)
Group C - Cord blood cell
Conventional treatment, cord blood cell transplant and placebo
干预措施: Placebo (Other)
Group A - Control
Conventional treatment and placebo
干预措施: Conventional Treatment (Procedure)
Group A - Control
Conventional treatment and placebo
干预措施: Placebo (Other)
Group B - Lithium Carbonate
Conventional treatment and lithium carbonate
干预措施: Conventional Treatment (Procedure)
Group B - Lithium Carbonate
Conventional treatment and lithium carbonate
干预措施: Lithium Carbonate Tablet (Drug)
Group D - Combination Therapy
Conventional treatment, cell transplant and 6-weeks course of lithium carbonate
干预措施: Lithium Carbonate Tablet (Drug)
Group D - Combination Therapy
Conventional treatment, cell transplant and 6-weeks course of lithium carbonate
干预措施: Cord Blood Cell (Biological)
结局指标
主要结局
Change from Baseline in AIS Motor and sensory scores and ASIA Impairment Scales in 48 weeks
时间窗: Week 0, 1, 2, 6, 14, 24 and 48
次要结局
- Walking(Week 2, 6, 14, 24, 48)
- Functional assessment(Week 2, 6, 14, 24, 48)
- Locomotion(Week 2, 6, 14, 24, 48)
- Spasticity grade(Week 2, 6, 14, 24, 48)
- Pain(Week 2, 6, 14, 24, 48)