To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability.
研究概览
简要总结
This is a Phase I/II, multicenter, prospective, non-randomized, open label study to evaluate the safety/efficacy of autologous bone marrow-derived stem cell transplantation in spinal cord injury patients.
详细描述
Spinal cord injury (SCI) is a traumatic disorder resulting in a functional deficit that usually leads to severe and permanent paralysis and the projected data related to the burden of spinal cord injuries across the globe is quite alarming. Pharmacological and rehabilitation therapies to SCI have got limited effect. There is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully. Another promising therapeutic approach for SCI is "Stem cell transplantation". Bone marrow derived stem cells have been shown to promote anatomical and functional recovery in animal models of SCI by promoting tissue sparing, axonal regeneration, and remyelination. In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted intrathecally into patients with spinal cord injury.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic injury of the spinal cord (below C5 level) occurring within 6 months to 8 years prior to treatment, resulting in a sustained and complete / Partial loss of sensory and motor function below the injury (ASIA Category A, B and C ).
- •Confirmation spinal cord injury level (Patients with complete or partial transection/damage by MRI).
- •Those provide fully informed consent.
- •The level of spinal cord injury must be below C4.
排除标准
- •Spinal vertebral instability.
- •Major concurrent medical illness (e.g. carcinoma, auto-immune disease,)
- •ASIA Impairment Scale category other than D & E.
- •Lactating and pregnant women.
- •Syringomyelia is also an exclusion criterion but an exemption can be made for a patient with a stable syrinx.
- •Platelet count greater than 100 thousand/µl at screening.
- •Hematocrit less than 30% prior to bone marrow aspiration.
- •Patients with major and current psychiatric illness.
- •Significant traumatic brain injury associated with the spinal cord injury.
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability.
时间窗: 18 months
The measure is the number of adverse events following intrathecal administration of autologous bone marrow derived stem cells in spinal cord injury patients.
次要结局
- Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function.(18 months)
研究者
Yashbir Dewan
Consultant Neurosurgeon
Max Institute of Neurosciences