Surgical Transplantation of Autologous Bone Marrow Stem Cells With Glial Scar Resection for Patients of Chronic Spinal Cord Injury and Intra-thecal Injection for Acute and Subacute Injury - A Preliminary Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of Participants with adverse events as a measure of safety and tolerability. Significant clinical improvement in ASIA impairment scale and general condition
研究概览
简要总结
The projected data related to the burden of spinal cord injuries induced limb paralysis in India is quite alarming. This is attributed to the rapid industrialization and economical development in the country. Increase in vehicular traffic has caused numerous road traffic accidents. Rapid increase in populations, development in the computer technology and real estate business lead to construction of huge buildings which indirectly adds to the injuries due to fall. Spinal cord injuries could not be treated adequately with the prevailing treatment modalities. In view of this, 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. Since a large number of these patients will loose their productive life and at the prime of their lives, one such alternate therapy, which seems to offer some promise, is "stem cell" therapy, which has been well studied and published in prestigious journals.
In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted directly into the lesion site with glial scar resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for 4 indian patients of acute and subacute injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to give voluntary (patients may not be able to write) consent.
- •Must be able to understand study information provided to him.
- •Patients with complete spinal cord trans-section: at least post 6 months after spinal cord Injury (in chronic patients), < 2 weeks in acute category and 2-8 weeks in subacute patients.
- •The level of spinal cord injury must be between C4 and T12(neurological level)
- •Spinal cord injury categorized in terms of ASIA Impairment scale.
- •Age should be between 20-55 years
排除标准
- •Mechanical ventilation due to neurological impairment
- •Multiple level trauma
- •Undetermined size and location of Spinal Cord injury
- •Gunshot or other penetrating trauma to the spinal cord
- •Longitudinal dimension of injury by MRI is greater than 3spinal segments
- •Associated severe head injury
- •More than 9cms long bone fracture
- •Women who are pregnant or lactating
- •Serious pre-existing medical conditions
- •Disease or impairment that precludes adequate neurological examination.
- •Should not have co-morbidities like Diabetes, Systemic Hypertension etc.
- •Severe co-morbidities/bed sores Tests positive for infectious diseases Deranged Coagulation profile and Hb < 8mg/dl
结局指标
主要结局
Number of Participants with adverse events as a measure of safety and tolerability. Significant clinical improvement in ASIA impairment scale and general condition
时间窗: 18 months
American Spinal Injury Assessment scale of A,B,C,D or E
次要结局
- Changes in the MRI, Neurological improvement (cranial/spinal reflexes) and evoked potentials study(18 months)