Safety and efficacy of biological scaffolds in patients with spinal cord injury
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Improvement in the American Spinal Injury Association (ASIA) score, Functional independence measure (FIM) scores
研究概览
简要总结
This study aims to evaluate the safety and efficacy of a biological scaffold in patients with acute spinal cord injury. It is a randomized comparative study involving surgical fixation with or without scaffold treatment. The scaffold is combined with exosomes and autologous bone marrow concentrate to support neural recovery. Participants will be monitored for neurological improvement and quality of life over a 2-year period using standard scoring systems. The research is a multi-institutional collaboration between IMS BHU and IIT Kanpur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Acute spinal cord injury within 1 week having ASIA score A morbidity.
排除标准
- •Previous spinal surgeries, associated multisystem injuries, inability to comply with follow-up, no associated comorbidities.
结局指标
主要结局
Improvement in the American Spinal Injury Association (ASIA) score, Functional independence measure (FIM) scores
时间窗: 3, 6, 12 months and then yearly for 2 years.
次要结局
- Quality of life assessed by the EQ-5D scale, SCIM spinal cord independence measure, functional (10MWT, 6MWT, TUG, WISCI2)(1 month, 3 months, 6 months, 12 months, 2 years)
研究者
Dr Sanjay Yadav
Institute of Medical Sciences, Banaras Hindu University