Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Examine for improvement in the ASIA classification.
研究概览
简要总结
Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and feasibility of autologous bone marrow cell transplantation in case of acute complete spinal cord injury by each of the following techniques and a corresponding number of controlled subjects:
- Directly into the injured site with a syringe after exposing the spinal cord.
- By Intrathecal injection.
详细描述
Intervention : Autologous bone marrow cell: Transplantation of the autologous bone marrow cell transplantation through one of the below mentioned techniques: 1. Directly into the injured spinal cord site with a syringe after exposing the spinal cord. 2. By Intrathecal injection. Number of cells Injected: 200 million cells in 1.8 ml of autologous plasma. In case of Direct delivery, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal injection, the cells were delivered as a single injection of 1.8ml via lumbar puncture. Frequency of Injection: Single Total duration of Therapy: The procedure of Bone marrow harvesting, enrichment and transplantation was completed in a single setting of approximately 2-3 hours. The transplantation procedure in case of Direct delivery took 2 mins per injection site that is approximately 12 mins and in case of lumbar puncture the transplantation procedure took approximately 2 mins.
Comparator Agent:Control: control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute spinal cord injury between 10 days and 14 days post injury.
- •The subject must have a traumatic spinal cord injury between the spinal segmental levels T1 and T12 (Neurological Level).
- •Must have a complete injury (ASIA-A).
排除标准
- •Subject whose medical condition requires mechanical ventilation.
- •Subjects with neurological level of injury above T1 and below T
- •Subjects more than 14 days and less than 10 days post-injury.
- •Lower motor neuron injury.
- •Subjects with pathological fracture.
- •Spinal Injuries in subjects with Ankylosing Spondylitis.
- •Subjects with extremes of age: less than 18 years or more than 50 years.
- •Subjects with pre-existing severe medical disease which would affect the outcome like severe diabetes, rheumatoid arthritis.
- •Subjects with Psychological disorders.
- •Female subjects with pregnancy.
研究组 & 干预措施
Control
control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation.
Transplantation via intrathecal route
Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via lumber puncture
干预措施: autologous bone marrow cell (Biological)
Transplantation via intralesional route
Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via durotomy and injection at the lesional site .
干预措施: autologous bone marrow cell (Biological)
结局指标
主要结局
Examine for improvement in the ASIA classification.
时间窗: up to 5 years
Blinded assessors will examine for improvement in the ASIA classification of at least one grade by 12 months or change from baseline of 10 points or more in total motor score, with consideration of their distribution along the neuraxis, from the ASIA Impairment Scale (AIS) manual motor test by 12 months.
次要结局
- Improvements in SCIM score(up to 5 years)
- Improvements in SSEP(up to 5 years)
- Improvements in any of the variables included in ISCIS(up to 5 years)
- Psychological evaluation(up to 5 years)
- Significant change in any of the variables included in urodynamic assessment(up to 5 years)
- Improvement in ASIA sensory examination(up to 5 years)
- Improvements in EMG(up to 5 years)
- Any voluntary movement by additional muscle groups not included in International Standards for Neurological Classification of Spinal Cord Injury(up to 5 years)
- Improvements in MEP(up to 5 years)
- Improvement by at least 1 point on the WISCI scale(up to 5 years)
- Decrease in spasticity by one grade or more as assessed by Modified Ashworth Spasticity Scale(up to 5 years)