Different Efficacy Between Rehabilitation Therapy and Umbilical Cord Derived Mesenchymal Stem Cells Transplantation in Patients With Chronic Spinal Cord Injury in China
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Assessment of changes in International Standards for Neurological Classification of Spinal Cord Injury according to American Spine Injury Association
研究概览
简要总结
The morbidity of spinal cord injury (SCI) is increasing year by year significantly in China. The methods to treat SCI patients in sequela stage update are poor. Though traditional rehabilitation therapy is the routine method to treat SCI in sequela stage, aiming to improve the neurological disorders of these patients, such as sensory disturbance, dyskinesia, autologous adjustment of blood pressure, dysfunction of urination, defecation and perspiration , etc. What's a pity, the efficacy of the rehabilitation therapy is unsatisfactory. Rehabilitation Therapy can prevent the process of muscle atrophy and joint stiffness. However, it can not repair the damaged nerve function. Studies show that mesenchymal stem cell transplantation can remarkably improve the neurological function of SCI in animals without any severe side effect.
In this study, 300 patients will be divided into three groups and the investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 SCI patients. They will also follow up 100 patients who only receive rehabilitation and another 100 patients who accept neither stem cell therapy nor rehabilitation. On this basis, the investigators can compare the efficacy of these two treatments.
详细描述
Patients enrolled in this study need to finish our whole follow-up survey, which is carried out by clinical doctors and epidemiologist.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients or their curator must be able to give voluntary consent.
- •Patients have clear history of traumatic injury.
- •20 years - 65 years of age can be enrolled.
- •Both male and female can be enrolled.
- •The diagnosis of spinal cord injury are confirmed by all of the examinations including MRI, electromyogram and electrophysiology.
- •The time of injury was longer than 1 year.
排除标准
- •Mental disorders
- •Women in pregnancy
研究组 & 干预措施
rehabilitation
Patients in the group accept rehabilitation for three weeks in hospital and other eleven months in their home under the guidance of physical therapist.
干预措施: rehabilitation (Other)
cell therapy
Patients in the group accept cell therapy including four times stem cells transplant via intrathecal injection.
干预措施: cell therapy (Biological)
control
Patients receive no professional treatment in hospital or rehabilitation centre.
结局指标
主要结局
Assessment of changes in International Standards for Neurological Classification of Spinal Cord Injury according to American Spine Injury Association
时间窗: Baseline, 6 and 12 months after recruitment
ASIA is American Spine Injury Association.The ASIA publishes the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), which is a neurological exam widely used to document sensory and motor impairments following spinal cord injury (SCI). The ASIA assessment is the gold standard for assessing SCI. The exam is based on neurological responses, touch and pinprick sensations tested in each dermatome, and strength of the muscles that control key motions on both sides of the body. Muscle strength is scored on a scale of 0-5 according to the adjacent table, and sensation is graded on a scale of 0-2: 0 is no sensation, 1 is altered or decreased sensation, and 2 is full sensation. Each side of the body is graded independently. The ISNCSCI exam is used for determining the neurological level of injury. ASIA Impairment Scale for classifying spinal cord injury includes five grades: A, B, C, D and E.
次要结局
- Assessment of changes in score of pain index using Short-form McGill Pain Questionnaire(Baseline,6 and 12 months after recruitment)
- Assessment of changes in sensory evoked potentials and motor evoked potentials(Baseline,6 and 12 months after recruitment)
- Assessment of changes in score of activity of daily living(Baseline, 6 and 12 months after recruitment)