Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury (ABMST-SCI)
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
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.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
-
-
Karnataka
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Bangalore、Karnataka、印度、560025
- Sita Bhateja Speciality Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Intralesional
|
surgical laminectomy with glial scar resection
|
|
实验性的:intrathecal
direct into the CSF through lumbar puncture
|
direct into the CSF through lumbar puncture
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants with adverse events as a measure of safety and tolerability. Significant clinical improvement in ASIA impairment scale and general condition
大体时间:18 months
|
American Spinal Injury Assessment scale of A,B,C,D or E
|
18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in the MRI, Neurological improvement (cranial/spinal reflexes) and evoked potentials study
大体时间:18 months
|
MRI findings of the lesion, Nerve conduction studies of the region and somatosensory evoked potentials of the same region
|
18 months
|
合作者和调查者
调查人员
- 首席研究员:Dr.Arvind Bhateja, MCh.Neurosurgery、Sita Bhateja Speciality Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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